Events

Recall of HL-20 PERFUSION SYSTEM - ROLLER PUMP MODULES

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
    125724
  • Event Risk Class
    II
  • Event Initiated Date
    2011-06-28
  • 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
    In very rare cases it is possible for a hl 20 twin pump module (tpm) to unintentionally increase its speed for a 1.5 - 2 second period of time before returning to its originally set speed. this malfunction can only occur when the tpm is used for cardioplegia and set up in a master/ slave configuration. during the malfunction a very transient incorrect mixing of the cardioplegia solution can occur before the pump speed returns to its original setting. this behavior can only occur when one of the tpm pumps is set as cardioplegia slave and the as cardioplegia master pump. when the tmp is used in any other confirguation this malfunction does not occur.

Device

HL-20 PERFUSION SYSTEM - ROLLER PUMP MODULES
  • Model / Serial
    Model Catalog: TPM 20-330 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    HL-20 PERFUSION SYSTEM - ROLLER PUMP MODULES
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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