BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 973454 · Received April 27, 2006

    Report

    Report Number
    9616240-2006-00281
    Event Type
    Malfunction
    Date Received
    April 27, 2006
    Manufacturer
    *
    Product Code
    FII
    PMA / PMN Number
    k001156
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INTERVENTION WAS REQUIRED. ACTUAL HEPARIN DELIVERY UNK. A GAMBRO TECHNICAL SERVICES (GTS) FIELD REP FOUND HEPARIN SYRINGE CONTAINED A SMALL AMOUNT OF BLOOD/FLUID AND AIR, SINCE IT PRESUMABLY MOVED BACKWARDS. THIS MIGHT EXPLAIN WHY THE ACTUAL DELIVERY HEPARIN COULD NOT BE DETERMINED. THE SERVICE TECH WAS UNABLE TO DUPLICATE THE REPORTED FAILURE. HE CHECKED MANUAL OPERATION OF HEPARIN PUMP AND VERIFIED VOLTAGE. HE PERFORMED A SIMULATED PT RUN WITH SIMILAR PROGRAMMED VALUES AND HEPARIN PUMP DELIVERED ACCURATE VOLUME. NO UNUSUAL MOVEMENT OF SYRINGE WAS NOTED. NO MACHINE PROBLEM IDENTIFIED. CUSTOMER USED THE MACHINE SEVERAL TIMES SINCE INCIDENT, MACHINE WORKED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * FII * * *

    Patients

    Seq Age Sex Outcome Treatment
    1