BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 810886 · Received January 24, 2007

    Report

    Report Number
    810886
    Event Type
    Injury
    Date Received
    January 24, 2007
    Date of Event
    November 22, 2006
    Report Date
    January 24, 2007
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    HEPARIN INFUSION VIA PUMP. SHOULD HAVE DELIVERED 6 ML PER READING ON PUMP. SYRINGE STILL FULL AT 48.5 ML. NO VOLUME DELIVERED TO PATIENT ACCORDING TO SYRINGE LEVEL. PROBLEM IDENTIFIED BECAUSE PATIENT WAS ON ECMO AND HAVING REGULAR ACTIVATING CLOTTING TIMES DONE. CLOTTING TIME DECREASED FROM 202 TO 184 TO 155 IN 1 HOUR. PUMP SENT TO SMITHS MEDICAL FOR EVALUATION AND REPAIR. COMPANY FOUND THAT CLUTCH SPRING WAS BROKEN CAUSING THE TACK TO MOVE FREELY WITHOUT PRESSING THE CLUTCH. THIS WAS CAUSING THE PUMP TO COUNT EVEN THOUGH INFUSION WAS NOT HAPPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PUMP, SYRINGE FRN SMITHS MEDICAL 2001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DAY Required Intervention