Events

Recall of CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP

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
    105383
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-05
  • 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 continually monitors the performance of the cardiosave iabps and has discovered four issues that could affect the cardiosave iabp performance and may cause the cardiosave iabp to not meet performance specifications. the scroll compressor may not meet the performance specifications for output pressure or vacuum at specific flow rates. due to an unintended increased size in the his/cis connectivity packet the interface may reject the packet due to increased packet size and the his/cis may not be able to provide external data communications of electronic medical records as intended. the cardiosave iabp may have intermittent connectivity issues causing display blanking followed by a "system failure" audible alarm and shut down. during operation the cardiosave iabp may shutdown due to a short on the video generator board. intermittent connection with the cardiosave pneumatic module connector may result in iabp startup failure and/or iabp shutdown.

Device

CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP
  • Model / Serial
    Model Catalog: 0998-00-0800-53 (Lot serial: > 10 NUMBERS CONTACT MFG)
  • Product Description
    CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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