BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS ADMIN SET

    MDR report key: 3063810 · Received April 3, 2013

    Report

    Report Number
    9616066-2013-00224
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    September 14, 2012
    Report Date
    October 4, 2012
    Manufacturer
    CAREFUSION CORPORATION
    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

    (B)(4). A DUPLICATE MDR# 9616066-2012-00468 WAS CREATED. CORRECT MDR # IS 9216066-2013-00224. THE CUSTOMER'S REPORT THAT SOLUTION FREE FLOWED WAS CONFIRMED. THE SET WAS EVALUATED BY CAREFUSION. DURING VISUAL INSPECTION IT WAS NOTED THAT THE MEMBRANE DISC WAS OFF-CENTER. FUNCTIONAL TESTING WAS PERFORMED AND AIR BUBBLES WERE NOTICED GOING INTO THE PRIMARY BAG INDICATING A FAULTY CHECK VALVE. THE CHECK VALVE WAS SENT TO THE SUPPLIER FOR FURTHER EVALUATION. TESTING BY THE SUPPLIER ALSO INDICATED A FAULT CHECK VALVE DUE TO THE DISC BEING OFF CENTER. HOWEVER THE ROOT CAUSE OF THE DISC BEING OFF CENTER WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED MAGNESIUM SULFATE WAS HUNG AND PROGRAMMED AS A SECONDARY INFUSION. AFTER THE START KEY WAS PRESSED THE NURSE NOTED THE SOLUTION WAS FREE FLOWING. THE INFUSION WAS STOPPED AND A NEW BAG OF MAGNESIUM, IV TUBING AND PUMP WAS STARTED. NO PT HARM OR MEDICAL INTERVENTION REPORTED. THE CUSTOMER DID NOT PROVIDE ANY ADD'L PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135500 ALARIS ADMIN SET FPA CAREFUSION CORPORATION 2420-050 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS SECONDARY SET: MODEL 11448964, LOT: UNK| ALARIS PC UNIT: SN UNK| ALARIS PUMP MODULE: SN (B)(4)