Events

Recall of PERMANENT LIFE SUPPORT SET

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
    54480
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-07
  • 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 december 2014 maquet cardiopulmonary notified you via dyr 91 (fsn 2014-12-11) of the increased incidence of blood leakage from the gas outlet connector of the quadrox-id adult and small adult products including the hls and pls sets that contain related oxygenators of this product family. the increased leakage was due to a separation of a small number of the internal fibers from the polyurethane casting in the oxygenator. this separation resulted in the blood leakage that was the subject of the field safety notice. since the release of this notification we have been able to confirm the possible root cause that was described in the notification. additionally we have implemented and validated the necessary corrections that return the products to their original performance specifications. the correction necessary was the implementation of additional process controls during the production process of these fibers at our raw material supplier. the fibers produced under these increased process controls have now been delivered to maquet cardiopulmonary and used on the production of the finished oxygenator products.

Device

PERMANENT LIFE SUPPORT SET
  • Model / Serial
    Model Catalog: BE-PLS 2050 (Lot serial: > 10 numbers contact mfg); Model Catalog: BE-PLS 2051 (Lot serial: > 10 numbers contact mfg); Model Catalog: BE-HLS 5050 (Lot serial: > 10 numbers contact mfg); Model Catalog: BE-HLS 7050 (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HQV 52305 (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HQV 52302 (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HQV 52306 (Lot serial: > 10 numbers contact mfg); Model Catalog: HMOD 70000-USA (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HLS 7050-CA (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HLS 5050-CA (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HMOD 70000-USA (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HMOD 70000 (Lot serial: > 10 numbers contact mfg); Model Catalog: BE-HMOD 70000 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    PERMANENT LIFE SUPPORT SET
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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