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:
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.
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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.
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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.
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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
