BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PERFUSION PACK

    MDR report key: 171541 · Received June 4, 1998

    Report

    Report Number
    1217435-1998-00132
    Event Type
    Malfunction
    Date Received
    June 4, 1998
    Date of Event
    May 12, 1998
    Report Date
    May 20, 1998
    Manufacturer
    TEXAS MEDICAL PROD.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE UNIT LEAKED DURING BYPASS. THE CONNECTION WAS TIE BANDED AND THE UNIT WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY OR FURTHER COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT. NO PT INFO OR FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD PERFUSION PACK CUSTOM TUBE PACK DWF TEXAS MEDICAL PROD. NA 28LHX134

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN