Events

Recall of ADVANCED PERFUSION SYSTEM 1 - ROLLER PUMP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TERUMO CARDIOVASCULAR SYSTEMS CORP..

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
    46283
  • Event Risk Class
    II
  • Event Initiated Date
    2008-10-23
  • 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
    Roller pumps failed to power up or experienced unplanned pump stop due to supplier workmanship issues affecting an internal circuit board. the failures may nonrecoverable or may be intermittent in nature.

Device

ADVANCED PERFUSION SYSTEM 1 - ROLLER PUMP
  • Model / Serial
    Model Catalog: 801040 (Lot serial: 0113-0527); Model Catalog: 801041 (Lot serial: 0113-0527); Model Catalog: 801041 (Lot serial: 0028-0111); Model Catalog: 801040 (Lot serial: 0028-0111); Model Catalog: 801041 (Lot serial: 2587-2594); Model Catalog: 801040 (Lot serial: 2587-2594); Model Catalog: 801041 (Lot serial: 2581-2583); Model Catalog: 801040 (Lot serial: 2581-2583); Model Catalog: 801041 (Lot serial: 2239-2242); Model Catalog: 801040 (Lot serial: 2239-2242); Model Catalog: 801041 (Lot serial: 2230-2235); Model Catalog: 801040 (Lot serial: 2230-2235); Model Catalog: 801041 (Lot serial: 1607); Model Catalog: 801040 (Lot serial: 1607); Model Catalog: 801041 (Lot serial: 1584-1587); Model Catalog: 801040 (Lot serial: 1584-1587); Model Catalog: 801041 (Lot serial: 1577-1581); Model Catalog: 801040 (Lot serial: 1577-1581); Model Catalog: 801041 (Lot serial: 1575); Model Catalog: 801040 (Lot serial: 1575); Model Catalog: 801041 (Lot serial: 1572); Model Catalog: 801040 (Lot serial: 1572); Model Catalog: 8010
  • Product Description
    advanced perfusion system 1 roller pmp
  • Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.

Manufacturer

TERUMO CARDIOVASCULAR SYSTEMS CORP.
  • Manufacturer Address
    ANN ARBOR
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    HC