BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 5917736 · Received August 31, 2016

    Report

    Report Number
    9616066-2016-01132
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Date of Event
    July 11, 2016
    Report Date
    August 9, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: NON-CFN SECONDARY SET; 250ML BAXTER BAG NDC0338-001702, LOT Y202580, EXP DEC 2017, ACETYLCYSTEINE AND 5% DEXTROSE; 500ML BAXTER BAG, LOT Y200717, EXP AUG 2017, 0.9% SODIUM CHLORIDE INJECTION; THERAPY DATE UNKNOWN. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT THAT THE SECONDARY INFUSED INTO THE PRIMARY WAS CONFIRMED. FUNCTIONAL TESTING CONFIRMED BACKFLOW INDICATING A FAULTY CHECK VALVE. DISASSEMBLY OF THE CHECK VALVE RESULTED IN NORMAL FINDINGS. NO PARTICULATES WERE NOTED ON THE DIAPHRAGM MEMBRANE. THE ROOT CAUSE OF THE BACKFLOW WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY (B)(4).

    Description of Event or Problem · 1

    THE SET WAS RECEIVED AS AN UNEXPECTED RETURN LABELED FOR A SEPARATE COMPLAINT WHICH WAS REGARDING BACKFLOW FROM A SECONDARY BOTTLE INTO THE PRIMARY BAG. THE CUSTOMER LATER REPORTED THEY WERE UNSURE BUT THINK THIS SAMPLE MAY HAVE BEEN INVOLVED IN A SIMILAR EVENT WITH A CHECK VALVE FAILURE DURING A SECONDARY BAG INFUSION OF ACETYLCYSTEINE. THERE WAS NO REPORT OF ANY PATIENT HARM.

    Description of Event or Problem · 1

    RECEIVED A COPY OF THE CUSTOMER MEDWATCH FROM THE FDA WHICH STATES;"FOSCARNET WHICH IS PREPARED IN GLASS BOTTLE WAS HUNG AS SECONDARY. STARTED DRIPPING FASTER THAN WHAT SEEMED APPROPRIATE FOR PUMP SETTING. VERIFIED HUNG PROPERLY, CHANNEL CHANGED OUT AND RETRIED. DISCOVERED THAT IT WAS BACK FLOWING INTO THE PRIMARY BAG. ENDED UP HAVING TO CLAMP PRIMARY IN ORDER FOR SECONDARY TO RUN. MEDICATION RUNNING AT END OF SHIFT INSTRUCTED DAYSHIFT RN TO SAVE TUBING IF POSSIBLE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569672 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2426-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR