Events

Recall of HL-20 PERFUSION SYSTEM - HEATER-COOLER SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED INC..

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
    96622
  • Event Risk Class
    II
  • Event Initiated Date
    2016-08-29
  • 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
    Maquet cardiopulmonary ("mcp") as well as european health authorities have received reports confirming the presence of mycobacterial contamination (and other bacterial contamination) in the system water of heater-cooler devices used during short-duration cardiopulmonary bypass procedures to warm or cool a patient. although the water in the heater-cooler unit circuits does not come into direct contact with the patient there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) via the device's exhaust vent into the environment and to the patient. mcp has confirmed that maquet heater cooler units may become contaminated with various strains of bacteria that also include mycobacteria species. however there have been no reported adverse events diseases or illnesses associated with mycobacteria contaminations. maquet has not received any reports of patient mycobacteria infections resulting from surgery involving heater cooler units. mcp has determined that the listed product may possess the potential for bacterial contamination to occur. you are being contacted because you have been identified as a device user of one or more maquet heater cooler units.

Device

HL-20 PERFUSION SYSTEM - HEATER-COOLER SYSTEM
  • Model / Serial
    Model Catalog: HCU 20-603 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: HCU 20-600 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: HCU 20-601 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: HCU 20-602 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 70104.4054 (200-240V) (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 70105.4917 (110-120V) (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 70104.9090 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 00705501 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 00939001 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 00704629 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    Heater-Cooler Unit HCU 20;Heater-Cooler Unit HCU 40;Heater Unit HU 35;Heater-Cooler Unit HCU 30
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC