BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 3003741 · Received February 12, 2013

    Report

    Report Number
    1722139-2013-00071
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 11, 2013
    Manufacturer
    MOOG MEDICAL
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADMINISTRATION SETS WERE NOT RETURNED DUE TO CUSTOMER ALREADY HAD DISCARDED THEM. THE ASSOCIATED PUMP WAS RETURNED. DHR FOR ADMINISTRATION SET WAS REVIEWED AND SHOWED NO DEFECTS. INVESTIGATION ON PUMP SHOWED THAT PUMP PASSED 40 PSI TEST AND OTHER FUNCTIONAL TESTS. VOLUMETRIC TESTS SHOWED THAT THE PUMP INFUSED IN THE CORRECT FORWARD DIRECTION AND THE INFUSIONS WERE LOW. A PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED BY THIRD PARTY ON (B)(4) 2013. PUMP¿S MAINTENANCE DUE DATE WAS CHANGED FROM 07/06/2013 TO 01/15/2014. PUMP¿S CALIBRATION DATA VALUES ARE STILL THE SAME WHEN COMPARED TO THE DHR. PUMP WAS RE-CALIBRATED TO RESOLVE THE UNDER INFUSIONS. COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    INFO RECEIVED FROM A PHARMACIST¿S NOTE ALLEGES THAT TUBING HAS A REVERSE FLOW. WIFE HOOKED PATIENT UP TO THE TPN AND WHEN SHE RAN THE PUMP, PATIENT¿S BLOOD STARTED COMING INTO THE LINE AND UP THE TPN TUBING. SHE STOPPED THE PUMP AND WAS WONDERING WHAT SHE DID WRONG. PHARMACIST HAD HER DISCONNECT THE TUBING FROM PATIENT, FLUSH HIS LINE WITH NSS, RUN THE PUMP WITHOUT IT BEING HOOKED UP TO PATIENT BUT RUN BACKWARDS (FLUIDS GOING BACK INTO THE BAG INSTEAD OF OUT). PHARMACIST ASKED HER TO TAKE THE TUBING OUT MANUALLY PRIME THE SET AGAIN PLACE IT BACK IN THE PUMP AND RUN. AGAIN, THE FLUIDS RAN BACK INTO THE BAG. PHARMACIST HAD HER START OVER WITH A NEW TPN BAG AND A NEW ADMINISTRATION SET BUT THE SAME THING HAPPENED AGAIN. SHE TOOK THE TUBING OUT AND PUT IT BACK INTO THE PUMP THEN STARTED IT AGAIN. THIS TIME THE TPN FLOWED IN THE CORRECT DIRECTION SO SHE HOOKED IT UP TO THE PATIENT. HOWEVER, PATIENT¿S BLOOD BEGAN COMING OUT OF HIS LINE AND INTO THE TPN TUBING AGAIN. PHARMACIST HAD HER DISCONNECT AND FLUSH PATIENT¿S LINE WITH 2 NSS AND 1 HEPARIN FLUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61321 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL 340-4128 CF1216705

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR TPN