BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4725031 · Received April 23, 2015

    Report

    Report Number
    9616066-2015-00525
    Event Type
    Malfunction
    Date Received
    April 23, 2015
    Date of Event
    April 8, 2015
    Report Date
    April 9, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BAXTER 1000ML IV BAG OF 0.9% NACL, LOT C972521, EXP. SEPTEMBER 2016; PFIZER 50ML IV BAG OF ZOSYN ¿PIPERACILLIN AND TAZOBACTAM INJECTION¿, LOT: LN094417, EXP: OCTOBER 14, 2015. CONCLUSION CODE FIELD LEFT BLANK - NO AVAILABLE CODE FOR UNDETERMINED OR UNKNOWN CAUSE. THE CUSTOMER¿S REPORT OF SECONDARY BACK FLOW INTO THE PRIMARY SET WAS CONFIRMED. THE PRIMARY AND SECONDARY SETS WERE VISUALLY INSPECTED AND NO ANOMALIES WERE OBSERVED. THE CHECK VALVE WAS VISUALLY INSPECTED UNDER MAGNIFICATION; IT WAS NOTED TO BE ASSEMBLED IN THE SET CORRECTLY, AND THE SILICONE MEMBRANE WAS CENTERED. FUNCTIONAL TESTING WAS PERFORMED; FLUID AND AIR BUBBLES WERE OBSERVED GOING INTO THE PRIMARY BAG AND TINTED TEST FLUID WAS OBSERVED TO HAVE GONE PAST THE CHECK VALVE, INDICATING A FAULTY CHECK VALVE. DISASSEMBLY OF THE CHECK VALVE RESULTED IN THE DISCOVERY OF A 0.0245 INCH LONG POLYVINYL CHLORIDE PARTICLE LOCATED BETWEEN THE HOUSING SEAL AREA AND THE SILICONE DIAPHRAGM DISK. THE ROOT CAUSE OF THE CHECK VALVE FAILURE IS A POLYVINYL CHLORIDE PARTICLE FOUND IN THE FLUID PATH WHICH PREVENTED THE SILICONE DIAPHRAGM FROM FULLY SEATING AGAINST THE HOUSING SEAL AREA. THE ORIGIN OF THE POLYVINYL CHLORIDE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN EMPTY MAGNESIUM SECONDARY WAS REMOVED AND DISCARDED AND A ZOSYN SECONDARY BAG WAS HUNG. THE NURSE THEN WENT BACK TO THE PUMP TO PROGRAM THE ZOSYN AND NOTED THAT THE PUMP STILL SHOWED 25ML LEFT TO INFUSE FOR MAGNESIUM, EVEN THOUGH THE REMOVED BAG HAD BEEN EMPTY. THE NURSE THEN LOOKED AT THE ZOSYN AND SAW THAT IT WAS ALMOST EMPTY, EVEN THOUGH THEY HAD ONLY HUNG IT WITHIN THE PREVIOUS 2-3 MINUTES. THE NURSE THEN CLAMPED THE SECONDARY LINE, AND THEN NOTED THAT PRIMARY SALINE 1L BAG WAS ACTUALLY OVER-FILLED, AND IT APPEARED THAT THE IVPB'S HAD PROBABLY BEEN EMPTYING INTO IT. THERE IS NO REPORT OF PATIENT HARM. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270672 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2426-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4), THERAPY DATE (B)(6) 2015