Events

Recall of Sorin Perfusion System - S5/C5 Heart Lung Machine

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Cellplex Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-01283-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01283-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The manufacturer, sorin group deutschland gmbh has received reports of some malfunctioning em1 model shaft encoders in the pumps. the encoder housing can be exposed to excessive traction resulting in the speed encoder becoming non-responsive and displaying an error message "shaft angle encoder fault". this fault results in the encoder code wheel coming in contact with the silicone detector cover and drawing out the silicon material from the detector housing. if the pump module has to be replaced and the perfusionist is not able to maintain the blood flow within 3 minutes, the situation may lead to oxygen under supply. it may be necessary to hand crank the pump or operate the cp5 manually in case of a pump control failure.
  • Action
    Cellplex is advising users that the affected pumps should not be used as an arterial pump. Prior to the use of the affected pumps, users are advised to rotate the speed encoders to ensure that complete smooth transition occurs. If there is excessive traction, DO NOT use the pump. Cellplex is advising that all affected pumps used as arterial pumps will be replaced by loan pumps until the correction is performed. All affected units will be corrected by Cellplex.

Device

Sorin Perfusion System - S5/C5 Heart Lung Machine
  • Model / Serial
    Sorin Perfusion System - S5/C5 Heart Lung MachineS5 Roller PumpProduct Code: 10-80-00Multiple Serial NumbersS5 Double Roller PumpProduct Code: 10-85-00Multiple Serial NumbersS5 Control Panel for Mast Roller Pump 150Product Code: 28-95-80Serial#: 50E60933, 50E60951 and 50E60946Pump Control Panel (CP5)Product Code: 60-02-60Serial #: 60E10351 and 60E10353ARTG Numbers: 108387, 94208
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Cellplex Pty Ltd

Manufacturer

Cellplex Pty Ltd