Events

Recall of HEART LUNG PERFUSION PACK WITH SOFTLINE

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
    15307
  • Event Risk Class
    III
  • Event Initiated Date
    2014-01-28
  • 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
    The desired cardioplegia temperature may not be obtained when the plegiox cardthe desired cardioplegia temperature may not be obtained when the plegiox cardioplegia heat exchanger (plegiox) is used in conjunction with a heater/cooler ioplegia heat exchanger (plegiox) is used in conjunction with a heater/cooler unit. isolated field reports have indicated that a user could not reach a desired low cooling temperature of cardloplegic solution as the measured value of the cardioplegia temperature by the probe on the plegiox did not match the set temperature on the heater/cooler unit. this variation has been attributed to the position of the temperature probe at the port on the plegiox which may lead to temperature readings differing to a varying degree from the real temperature of the cardioplegic solution. the discrepancy between cardioplegia temperature measured at the probe of the plegiox and set water temperature on the heater/cooler unit may appear greater than typical during clinical use of the heater/cooler system.

Device

HEART LUNG PERFUSION PACK WITH SOFTLINE
  • Model / Serial
    Model Catalog: BO-HQV 48707 (Lot serial: 92122544); Model Catalog: BO-HQV 48707 (Lot serial: 92120338); Model Catalog: H 55807 (Lot serial: 92119752); Model Catalog: H 55807 (Lot serial: 92121728); Model Catalog: H 55807 (Lot serial: 92120638); Model Catalog: H 55807 (Lot serial: 92112815); Model Catalog: H 55807 (Lot serial: 92118294); Model Catalog: H 55807 (Lot serial: 92115326); Model Catalog: H 55807 (Lot serial: 92113665); Model Catalog: BEQ-HQV 46900 (Lot serial: 92119672); Model Catalog: BEQ-HQV 46900 (Lot serial: 92118001); Model Catalog: BEQ-HQV 46900 (Lot serial: 92109788); Model Catalog: BEQ-HQV 46900 (Lot serial: 92115723); Model Catalog: BEQ-HQV 46900 (Lot serial: 92110183); Model Catalog: BEQ-HQV 46900 (Lot serial: 92116526); Model Catalog: BO-HQV 59204 (Lot serial: 92115322); Model Catalog: BO-HQV 59203 (Lot serial: 92115322); Model Catalog: BO-HQV 47906 (Lot serial: 92115322); Model Catalog: BO-HQV 46901 (Lot serial: 92115322); Model Catalog: BO-HQV 66606 (Lot serial: 92117616); Model Catalo
  • Product Description
    HEART LUNG PERFUSION PACK WITH SOFTLINE
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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