BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD HIGH VOLUME ADMINISTRATION SET

    MDR report key: 1781597 · Received July 22, 2010

    Report

    Report Number
    MW5016855
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Date of Event
    June 9, 2010
    Report Date
    July 22, 2010
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S MOM HOOKED UP CADD TUBING TO LIPIDS TWICE AND THE SOLID TAB BROKE ON TWO OF HER TUBING SETS. SHE DID HAVE TO WASTE A BAG OF LIPIDS, BUT HAD EXTRA TUBING AND LIPIDS. IF THIS HAD HAPPENED WHEN SHE DIDN'T HAVE EXTRAS PT WOULD HAVE BEEN WITHOUT LIPIDS FOR SOME TIME. PT'S MOM HAS BEEN HOOKING UP PT'S LIPIDS SUCCESSFULLY FOR QUITE A WHILE NOW. I AM SURE IT WAS NOT USER ERROR. DATES OF USE: (B)(6) 2010-(B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD HIGH VOLUME ADMINISTRATION SET TUBING FPA SMITHS MEDICAL 084X20

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO