BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 6012330 · Received October 7, 2016

    Report

    Report Number
    9616066-2016-01400
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 23, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PHASEAL; NON-BD SECONDARY & EXTENSION SET; (2) BAXTER 250ML BAG OF 0.9% NACL INJECTION NDC (B)(4), LOT Y201772, EXP DEC 2017; BAXTER 250ML BAG OF TREMELIMUMAB, NDC (B)(4), LOT Y201772, EXP DEC 2017; BAXTER CLEARLINK SYSTEM EXT SET NON DEHP 0.22 MICRON FILTER, THERAPY DATE (B)(6) 2016. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF CHECK VALVE FAILURE WAS CONFIRMED. FUNCTIONAL TESTING CONFIRMED FLUID AND AIR BUBBLES GOING INTO THE PRIMARY BAG. BLUE FLUID WAS ALSO NOTED TO HAVE GONE PAST THE CHECK VALVE INDICATING A FAULTY CHECK VALVE. DISASSEMBLY OF THE CHECK VALVE PART RESULTED IN DISCOVERY OF A PARTICLE LOCATED BETWEEN THE HOUSING SEAL AREA AND THE AFFIXED SILICONE DIAPHRAGM DISK. THE SIZE OF THE PARTICLE WAS MEASURED TO BE 0.0853¿ LONG. THE PARTICLE WAS IDENTIFIED TO BE CELLULOSE. THE ROOT CAUSE OF THE BACK FLOW FAILURE IS DUE TO A PARTICLE FOUND IN THE FLUID PATH THAT PREVENTED THE SILICONE DIAPHRAGM FROM FULLY SEATING AGAINST THE HOUSING SEAL AREA. THE ORIGIN OF THE CELLULOSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SECONDARY INFUSION OF TREMELIMUMAB IN A 250ML BAG WAS PROGRAMED TO INFUSE AT 250ML/H AND CONNECTED TO A PRIMARY INFUSION OF 250ML OF NS. AFTER 30 MINUTES OF INFUSION, THE SECONDARY INFUSION BAG WAS NOTED TO BE EMPTY AND THE PRIMARY INFUSION BAG APPEARED TO BE FULLER THAN EXPECTED. THE RN ALSO NOTED THERE WAS NO BUBBLES OR AIR IN THE PRIMARY LINE AND THAT THERE WAS A BLOOD RETURN. TWO RNS CONFIRMED THE PUMP PROGRAMMING AND THE DRIP CHAMBER WAS NOTED TO BE DRIPPING AS EXPECTED. THE DEVICES WERE TESTED AND CLEARED IN THE FACILITY BIOMED DEPARTMENT. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663152 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10933805

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR (2) 8100, 8015, (B)(4), TD (B)(6) 2016