BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 743761 · Received June 30, 2005

    Report

    Report Number
    1212122-2005-00002
    Event Type
    Malfunction
    Date Received
    June 30, 2005
    Date of Event
    May 1, 2005
    Report Date
    June 1, 2005
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DWF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON UNITIAL EVAL OF THE EVENT, IT APPEARS THAT THE DEVICE MIGHT HAVE BEEN USED IN A MANNER INCONSISTENT WITH PRODUCT LABELING. THE PRODUCT COMPONENT THAT IS THE SUBJECT OF THIS REPORT IS LABELED FOR 6-HOUR USE (MAXIMUM), HOWEVER, IT APPEARS THAT THE DEVICE MAY HAVE BEEN IN USE FOR A PERIOD OF TIME SUBSTANTIALLY LONGER THAN 6 HOURS. FURTHER INVESTIGATION BY TERUMO WILL ASCERTAIN THE SPECIFIC DETAILS OF THE EVENT, AND WILL BE REPORTED IN A FOLLOW-UP MDR REPORT. ALL INFO INCLUDED IN THIS REPORT WILL BE MAINTAINED BY TERUMO CARDIOVASCULAR SYSTEMS FOR TRACKING, TRENDING AND ANALYSIS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE CENTRIFUGAL PUMP (INCLUDED IN THE CARDIOVASCULAR CONVENIENCE KIT 70921-01) CEASED TO PUMP BLOOD THROUGH THE CIRCUIT DURING AN ECMO EVENT, THEREBY REQUIRING A CHANGE OUT OF THE DEVICE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT TUBING CONVENIENCE KIT DWF TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NA FA03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN