Events

Field Safety Notices about Maquet/Datascope CS100i Intra-Aortic Balloon Pump (IABP) Maquet/Datascope CS100 Intra-Aortic Balloon Pump (IABP) Maquet/Datascope CS300 Intra-Aortic Balloon Pump (IABP)

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Getinge.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-07-17
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Maquet/getinge has received complaints involving the cs100/cs100i and cs300 iabps regarding the following issues: • false blood detection alarm, and • the ingress of fluids into the iabp affecting various electronic circuit boards. either issue could potentially prevent initiation or continuation of therapy. this field corrective action addresses both issues. maquet/getinge would like to inform our customers affected by the field corrections that the risk-benefit of using an affected cs100/cs100i or cs300 iabp should be assessed by your medical team for each patient, when no alternative iabp or alternative therapy is available. .

Device

Maquet/Datascope CS100i Intra-Aortic Balloon Pump (IABP) Maquet/Datascope CS100 Intra-Aortic Bal...
  • Model / Serial
    0998-UC-0446HXX; 0998-UC-0479HXX 0998-00-3013-XX; 0998-UC-3013-XX 0998-00-3023-XX; 0998-UC-3023-XX
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Getinge

Manufacturer

Getinge
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    AMPMDRS