BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET

    MDR report key: 2032756 · Received February 23, 2011

    Report

    Report Number
    2032756
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 23, 2011
    Manufacturer
    QUEST MEDICAL
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ERROR DISPLAYED ON MYOCARDIAL PROTECTION SYSTEM (MPS) CONSOLE(CARDIOPLEGIA SOLUTION CONTROL)ARRESTING AGENT OCCLUDED X3.====================== MANUFACTURER RESPONSE FOR MYOCARDIAL PROTECTION SYSTEM (MPS) DELIVERY SET, MPS DELIVERY SET======================WE TROUBLE SHOOTED THE DEVICE WITH TECHNICAL SUPPORT OF MANUFACTURER ON THE PHONE. THEY DETERMINED IT WAS A DEVICE INCIDENT. THEY SAID IT WAS AN ISOLATED INCIDENT AND I COULD USE PRODUCT FROM THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPS DELIVERY SET MPS DELIVERY SET DTR QUEST MEDICAL 5001102 0389541JO8

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR