Events

Recall of S5 HEART LUNG MACHINE - MAST MOUNTED ROLLER PUMPS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIVANOVA CANADA CORP..

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
    48497
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-11
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Sorin has become aware of an increased trend in reports of "fault in motor controller (433)" alarm message events with certain mast roller pumps (mrp) 85 (product code 10-88-60) manufactured between october 6 2011 and august 20 2013. the failure occurs following an intended pump stop. the mrp stops and provides a visual and audible alarm on the system panel. the alarm can be cleared by pressing the reset button and the pump restarted by turning the setting knob. all complaints are related to specific hme motor control circuit boards (product code 90-305-700).

Device

S5 HEART LUNG MACHINE - MAST MOUNTED ROLLER PUMPS
  • Model / Serial
    Model Catalog: 50-80-62 (Lot serial: HME LOT 12070074); Model Catalog: 50-80-62 (Lot serial: 50E50974); Model Catalog: 50-80-62 (Lot serial: 50E50973); Model Catalog: 50-80-62 (Lot serial: 50E50970); Model Catalog: 50-80-62 (Lot serial: 50E50969); Model Catalog: 50-80-62 (Lot serial: 50E50783); Model Catalog: 50-80-62 (Lot serial: 50E50799); Model Catalog: 50-80-62 (Lot serial: 50E50798); Model Catalog: 50-80-62 (Lot serial: 50E50797); Model Catalog: 50-80-62 (Lot serial: 50E50784); Model Catalog: 50-80-62 (Lot serial: 50E50800)
  • Product Description
    S5 MAST MOUNTED ROLLER PUMPS (MRP) 85
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    HC