BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PERFUSION PACK

    MDR report key: 242617 · Received September 22, 1999

    Report

    Report Number
    1222008-1999-00028
    Event Type
    Malfunction
    Date Received
    September 22, 1999
    Date of Event
    June 9, 1999
    Report Date
    June 16, 1999
    Manufacturer
    TEXAS MEDICAL PRODS.
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE 4:1 CARDIOPLEGIA LINES WERE REVERSED IN THE TUBING PACK AND WAS NOTED DURING BYPASS. THE PERFUSIONISTS CORRECTED THE LINES AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY OR FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD PERFUSION PACK CUSTOM TUBE PACK DWE TEXAS MEDICAL PRODS. NA 28BJX150

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN