Events

Recall of Sorin S5/C5 Perfusion System: S5 Single Roller Pump 150 and S5 Double Roller Pump 85 (Heart-lung Bypass System)

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-2012-RN-00961-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-09-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00961-1
  • 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
    There have been reports received of a "fault in motor controller" alarm message. if this occurs, the pump stops, an audible alarm sounds and a visual alarm is displayed as "fault in motor controller" on the system panel. on some occasions the circuit breaker of the pump on the emergency power pack may also trip.
  • Action
    Cellplex is informing the hospitals to quarantine the roller pumps until the affected components have been replaced by Cellplex. Unaffected roller pumps will be supplied by Cellplex as loan units, if required

Device

Sorin S5/C5 Perfusion System: S5 Single Roller Pump 150 and S5 Double Roller Pump 85 (Heart-lung ...
  • Model / Serial
    Sorin S5/C5 Perfusion System: S5 Single Roller Pump 150 and S5 Double Roller Pump 85 (Heart-lung Bypass System)S5 Single Roller Pump 150Product Code: 10-80-00Serial Number: 10E06300, 10E06301 and 10E06302S5 Double Roller Pump 85Product Code:10-85-00Serial Number: 10E51883ARTG Number: 108387
  • Manufacturer
    Cellplex Pty Ltd

Manufacturer

Cellplex Pty Ltd