BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIOPLEGIA DELIVERY SYSTEM

    MDR report key: 174037 · Received June 24, 1998

    Report

    Report Number
    MW1014063
    Event Type
    Other
    Date Received
    June 24, 1998
    Date of Event
    June 4, 1998
    Report Date
    June 15, 1998
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING INITIATION OF CARDIOPULMONARY BYPASS, HIGH POTASSIUM CARDIOPLEGIA SOLUTION WAS DELIVERED TO THE PT VIA THE QUEST MPS SYS. DURING DELIVERY A LEAK WAS NOTED AT A CONNECTION ON THE ARREST DELIVERY POUCH. THE CONNECTION WAS TIGHTENED BUT THE LEAK CONTINUED. THE MACHINE NEEDED TO BE TURNED OFF DURING CHANGE OUT OF THE DELIVERY POUCH. THE MACHINE WAS OFF FOR APPROX 7 MINS DURING RE-PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOPLEGIA DELIVERY SYSTEM * DWB QUEST MEDICAL, INC. MPS 8610

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other