BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 5145942 · Received October 13, 2015

    Report

    Report Number
    9616066-2015-01264
    Event Type
    Malfunction
    Date Received
    October 13, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 17, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BAXTER, 250ML IV BAG OF 0.5% DEXTROSE LOT: C980417 EXP: DECEMBER 2016; BAXTER, 50ML IV BAG OF 0.9% SODIUM CHLORIDE LOT: P335026 EXP: NOVEMBER 2016; THERAPY DATE (B)(6) 2015. (B)(4). THE CUSTOMER¿S REPORT OF A CHECK VALVE FAILURE WAS CONFIRMED. VISUAL INSPECTION IDENTIFIED NO ANOMALIES. FUNCTIONAL TESTING IDENTIFIED A FAULTY CHECK VALVE. SUPPLIER TESTING OF THE COMPONENT REVEALED THE PRESENCE OF THREE PARTICLES LOCATED BETWEEN THE HOUSING SEAL AREA AND THE AFFIXED SILICONE DIAPHRAGM DISK. THE SIZE OF THE PARTICLES MEASURED TO BE 0.0107¿, 0.0133¿ AND 0.0132¿ LONG. THE PARTICLES WERE IDENTIFIED TO BE COMPOSED OF BASE MATERIAL MINUSIL. THE CAUSE OF THE CHECK VALVE FAILURE IS DUE TO MINUSIL PARTICLES FOUND IN THE FLUID PATH, WHICH PREVENTED THE SILICONE DIAPHRAGM FROM FULLY SEATING AGAINST THE HOUSING SEAL AREA. THE ORIGIN OF THE MINUSIL PARTICLES WERE NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    CORRECTION TO INITIAL REPORTER ADDRESS.

    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 A SECONDARY 50ML BAG OF DEXAMETHASONE IN NS BACKFLOWED INTO THE PRIMARY IV BAG. THE NURSE QUICKLY STOPPED THE INFUSION; OBTAINED NEW TUBING AND MEDICATION, AND THE DEXAMETHASONE WAS GIVEN WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675679 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2426-0007 15075637

    Patients

    Seq Age Sex Outcome Treatment
    1