16 June 2015

Recall detail
Type of Product
Medical Device
TGA Recall Reference RC-2015-RN-00511-1 – PDF version here
Product Name/Description Sorin 1T & 3T Heater Cooler
(Perfusion system)
All serial numbers starting with 16SXxxxx are affected
ARTG Number: 194514
Recall Action Level :Hospital
Recall Action Classification :Class I
Recall Action Commencement Date :16/06/2015
Responsible Entity : Cellplex Pty Ltd

Reason / Issue
Sorin has become aware that the actual disinfection practices and the water maintenance that some users have been performing are not always conducted according to our Instructions for Use. Without vigilant performance of the disinfection and maintenance procedures per the Instructions for Use, organisms can multiply in a heater cooler device and potentially form biofilm.
Recall Action : Recall for Product Correction
Recall Action Instructions : Sorin Group is providing end users with additional instructions for cases where the heater cooler has not been maintained according to the Instructions for Use. The IFU has also been updated to include the additional cleaning instructions.
Contact Information
03 9799 7444 Cellplex

11 June 2015

[High Priority ] – A24543 : Various Heater-Coolers Used With Cardiopulmonary Bypass Machines: May Become Contaminated with Mycobacterium, Potentially Leading to Patient Infection
Medical Device Ongoing Action
Published: Thursday, June 11, 2015
UMDNS Terms:
• Heart-Lung Bypass Units [11969]
• Warming/Cooling Units, Patient [12068]
Product Identifier : Various Heater-Coolers Used With Cardiopulmonary Bypass Machines [Capital Equipment]
Geographic Regions: U.K.
Suggested Distribution: Cardiology/Cardiac Catheterization Laboratory, Clinical/Biomedical Engineering, Infection Control, OR/Surgery, Pulmonology/Respiratory Therapy, Risk Management/Continuous Quality Improvement

Problem: The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a Medical Device Alert ( MDA/2015/022 ) warning healthcare workers that a small number of patients underwent cardiac surgery with cardiopulmonary bypass and developed endocarditis and/or septicemia associated with Mycobacterium avium (M. avium) species. MHRA also states that a study suggests that the possible source of the M. avium is colonization by bacteria in the water used in heater-coolers. The original report and updates can be found on Public Health England’s website. MHRA also states that the overall infection risk is difficult to quantify because current practices for monitoring an operating room’s environmental integrity may not identify this slow-growing, resistant organism. The manufacturers have not confirmed the information provided in the source material.

Action Needed:
MRHA recommends that you do the following:
● Follow the manufacturer’s instructions for use (IFU) at all times, especially when cleaning and disinfecting affected product and sterile components.
● Review, update, and follow local protocols for water management practices, water quality, environmental hygiene, vigilance, and device maintenance of affected product.
● Review, update, and follow local risk assessments for the safe operation of heater-coolers.
● Identify whether there are any practices that could lead to transmission of organisms through aerosolization where there is water contact with other cardiac surgery equipment.
● Have systems in place to notify the manufacturer and MHRA if you observe specific risks with any affected product.
● Have systems in place to contact Public Health England (PHE) , or the respective health protection agencies of devolved administrations, if you have new cases of Mycobacteria infections.
● Report any adverse incidents to MHRA through the Yellow Card scheme .

For technical inquiries to MHRA:
Enitan Taiwo or Andrew Bent
Tel.: (020) 30807122 or (020) 30806079, respectively
E-mail: enitan.taiwo@mhra.gsi.gov.uk or andrew.bent@mhra.gsi.gov.uk , respectively.
For clinical inquiries to MHRA:
Neil McGuire
Tel: (020) 30806800
E-mail: neil.mcguire@mhra.gsi.gov.uk
Website: Click here
Northern Ireland:
Northern Ireland Adverse Incident Centre
Tel.: (028) 90523868
Email: NIAIC@dhsspsni.gov.uk
Website: Click here
Incident Reporting and Investigation Centre
Tel.: (0131) 2757575
E-mail: nss.iric@nhs.net
Website: Click here
Healthcare Quality Division
Tel.: (01267) 225278 or (02920) 825510
E-mail: Haz-Aic@wales.gsi.gov.uk
Inquiries to MHRA should cite reference no. MDA/2015/022 or 2014/007/016/081/003.
● Great Britain. Medicines and Healthcare Products Regulatory Agency. Heater-cooler devices used in cardiac surgery—risk of infection with
Mycobacterium species [online]. London: Department of Health; 2015 Jun 11 [cited 2015 Jun 11]. (Medical device alert; no.
MDA/2015/022). Available from Internet: Click here .
● For information on a previous action by Sorin regarding Mycobacteria contamination in Heater-Cooler devices, see Alert Accession No.
A22770 .
www.ecri.org . Printed from Health Devices Alerts on Wednesday, June 17, 2015 Page 1

7 May 2013

Temperature Probe Port of MYOtherm Heat Exchanger

Problem: The temperature probes for the MYOtherm Heat Exchangers (HE’s) would not fit into the port, this occurred on at least 15 separate units.

Contributing factors:The root cause was found to be a moulding issue which in a varying degree, left some excess plastic material in the TMA (Temperature Monitoring Adaptor) port of the MYOtherm resulting in a tight fit of the probe into the port.  Not all of the MYOtherms were affected.  The supplier was immediately notified and the moulding tool has been corrected by the supplier to mitigate this issue.  Further investigation has found that often, with some force, as you may have experienced, the probe can be inserted and the system will monitor temperature as intended when the collar of the probe is fully engaged and locked into place.

Advice: Users of this device should contact their Medtronic supplier

27 March 2013

Update: Urgent Recall for Product Correction RC-2013-00239-1
MAQUET Oxygenators – Blood Outlet Connector

Products affected:
All sizes and membrane types of QUADROX-i oxygenators, (excluded HLS oxygenators) i.e. QUADROX-i(D) Adult, Small Adult, Pediatric and Neonatal with SOFTLINE and BIOLINE Coating
– PLS-i gas exchanger in PLS Sets
– PLS-i gas exchanger in HIT PLS Sets
– QUADROX-iR with SOFTLINE Coating

Attention: Head Operating Theatres – Cardiac Surgery/Perfusion Department
Head ICU / ECMO Intensivist

MAQUET Australia, after consultation with the Therapeutic Goods Administration (TGA), wishes to advise you of an update to the Recall for Product Correction involving all MAQUET Oxygenators (RC-

In June 2012 MAQUET announced a field corrective action regarding the blood outlet connector on the above referenced MAQUET oxygenators. Please be aware that MAQUET was recently notified of an
event in which the patient expired following an apparent detachment of the oxygenator connector after approximately 5 days of use. Based upon the information available to us at that time, the reported
failure may be related to the scenario described in the June 2012 communication.

In the initial field corrective action, we reported that in some rare cases, the blood outlet connector may detach from the oxygenator housing. Following implementation of improvements in the manufacturing and as a result of the field corrective action in June 2012, the event occurrence has changed from less than 0.01% (1:10,000) to less 0.001% (1:100,000) of units shipped.

MAQUET is implementing both a short term and long term corrective actions to address the issue.
MAQUET will be providing users with a stainless steel retainer clamp. The clamp is intended to hold the oxygenator’s outlet and inlet ports in place and is an additional protective measure against the possible failure mode. The clamp will be provided to all oxygenator customers following validation. We anticipate the availability in March 2013. The clamp will be provided with Instructions for Use, videos and imagesto aid in setup and cleaning.

Longer term we are developing a mechanical fitting to replace the current glue joint. The availability ofthe permanent mechanical fitting solution is expected to be implemented late this year.

Until such time as the clamp is validated and available for clinical use, MAQUET wishes to emphasize that all oxygenator users maintain a high degree of vigilance during use. Also, as previously noted in our earlier communication, MAQUET recommends that users confirm the integrity of the connector prior use by manually attempting to manipulate the connector in the housing. If the connector is secure in the housing, use the device in accordance with the Instructions for Use. If the connector feels loose or appears to be cracked, please quarantine the unit immediately. MAQUET will replace any suspect
oxygenators which you identify.

Please note that there is a brief video available which illustrates a clinician confirming the integrity of an oxygenator (http://www.maquet.com/quadroxjune2012).

MAQUET Australia apologises for any inconvenience this notice may cause your organisation, but assures you that the safety of all patients and staff at your facility is our priority. Should you have any
questions in relation to this advisory, please do not hesitate to contact your local MAQUET Sales Consultant or the following MAQUET Division Managers relevant to your product line;

• PLS products Niranjeli Rajanayagam on 0431 659 926
• Quadrox products John Barrett on 0434 317 904

Nicole Ditrich
Regulatory Affairs & QA Manager

11 April 2011

Terumo Corporation Australian Branch wishes to advise that Terumo Cardiovascular Systems (Terumo CVS) has agreed to the terms of a consent decree with the U.S. Food and Drug Administration (FDA) to address FDA’s concerns regarding processes and procedures used at the company’s Ann Arbor, Michigan manufacturing facility.  The consent decree will not become effective until it is approved by a U.S. District Court, however we want to notify you as soon as possible.

An information package concerning this matter is attached and includes:

  1. Customer Letter
  2. A list of Frequently Asked Questions (FAQ), and
  3. Notification Guide.

This package will provide you with information regarding a consent decree, the details of the agreement between Terumo CVS and FDA and important information in regard to what we, your hospital and Terumo, need to do in order for us to continue to supply you with our products.

Please note that only products manufactured at Terumo CVS’ Ann Arbor plant are subject to the consent decree.  Such products include heart lung machines, parts and accessories such as TLink, CDI monitors, Sarns Cannulae and Catheters with a complete list on page 6 of the Guide.

The Notification Guide provides you with details of the consent decree, its impact on Terumo and potential impact on you.  The major impact is that your hospital, or you, will have to sign a Certificate of Medical Necessity in order to continue receiving supply of products or services for the affected products as listed in the Guide.

The “Instructions for Existing Users Regarding Certificate of Medical Necessity” can be found on pages 9 and 10 of the Guide with the Certificate being found on page 11.  Please note Terumo only needs this Certificate to be signed once in order for you to continue purchasing your existing products that are manufactured at Ann Arbor.

It is most important to understand the following:

  • You are under no obligation to purchase these products, however, by signing this Certificate you have signified that you are willing to continue receiving them.
  • The consent decree only affects Ann Arbor manufactured product.  It does not affect other products such as our entire oxygenator range, shunt sensors and cuvettes used with CDI monitors plus other products made in Japan or other parts of the USA.
  • All Terumo CVS products are safe to use.  The consent decree does not require Terumo CVS to remove, recall or perform any corrective actions on the products currently in clinical use.
  • Terumo is intent on remaining a global leader committed to its customers and the cardiovascular community.

Terumo will be delighted to answer any questions you may have in regard to this matter.  You can contact the undersigned or either of the following:

Colin Walker, General Manager: Colin_Walker@terumo.co.jp ; phone +61 (0)412 009 112, or your local Terumo Sales Manager: Petra Gardiner; phone +61 (0)412 173 286

25 March 2011

Sorin D903 EOS Oxygenator: Apparent Oxyenator Fibre Lealk in Sorin D903 EOS Oxygenator. On 22 and 24 March there have been 3 instances of oxygenator fibre leak in the Sorin D903 EOS oxygenator in one institution. The first resulted in frank blood in the gas header and leaking from the lower gas compartment during CPB with diminishing gas exchange over the 98 minute bypass that required increasing the gas to blood flow ratio to 1.4:1 and the FiO2 to 98%. All blood gas results were acceptable (PCO2 5.5 – 6.5KPA, PO2 12.2 – 30.8 KPA). The second occurred following termination of CPB while sequestering the residual prime volume to transfer packs with no impact on gas exchange during CPB. The third was very minor – a small amount of blood stained fluid in the gas compartment at thet base of the oxygenator. All devices were from LOT no. 1009130006. The supplier and manufacturer have been advised and the devices returned for investigation.


April 2007

Contaminated heparin alert

17 March 2008

Dideco Sidus cardioplegia heat exchanger: There has bee a cluster of Dideco Sidus cardioplegia heat exchangers that have an apparent fault. These do not cool optimally especially at lower flows and with increased line pressure. We have replicated the fault invitro post CPB. We suspect CP is shunting past the heat exchanger. The common serial number is 203735 – xxxx.  The supplier and TGA have been advised


3 May 2007

2 Stage Venous Cannula Failure(s): The tip of a dual stage venous cannula (Cardio Research CV3040N70DHC) was found to have detached from the rest of the cannula on decannulation. (i.e., the tip remained in the right atrium.) Note: incident was found to have occurred during post bypass decannulation).Batch #29671 No known contributing factors – (Have used these cannulas for over 10 years and this is the first time this has occurred.) Removed the main section of the venous cannula from the venous return line. Attached a new single stage cannula and went back on cardiopulmonary bypass in an attempt to retrieve the cannula tip. Cannula tip was located retrogradely in the groin and removed using a separate groin incision. The two stage venous cannula is constructed from four separate plastic components. The surgeon has said he will not use this cannula again and has instead selected a two stage cannula constructed from a single piece of plastic. Discussions are underway with manufacturer. At a cardiac surgical morning meeting the case of the disconnection of the 2 stage venous cannula (CV3040N70 DHC, Batch No. 29671) was presented. During this meeting a couple of examples of the cannula in question from the same batch were circulated among attendees to examine. During this examination, with just gentle flexing of the cannula tip, one of the surgeons, to his amazement, was able to detach it from the rest of the cannula. No known contributing factors. The cannulas had been taken out of their sterile packaging immediately prior to the meeting and were only provided for meeting attendees to understand fully the clinical problem as it presented itself. Company contacted and collected both faulty cannulas for examination as well as all our stock of these cannulas the following day. Part of the problem with these cannulas is that they are constructed from four separate pieces of plastic which are then bonded or glued together. Our solution is to change to a two stage venous cannula that is directly moulded as a single piece of plastic.

PIRS Ed – We recommend any users of this cannula to contact the supplier if unaware of this problem.

10 September 2006

Tubing Disconnection SMARxT from Venous reservoir outlet port. Four reports have been received of SMARxT tubing disconnection during CPB from the venous reservoir outlet port on Terumo SX25, Terumo SX25RX and Terumo RX15. All users of SMARxT tubing are advised to confirm their connection procedures, ties and tie gun specifications with their supplier. See relevant abstract