BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2190053 · Received June 29, 2011

    Report

    Report Number
    2016493-2011-00401
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER STATED THE DEVICE ASSOCIATED WITH THIS EVENT WILL NOT BE RETURNED AND DECLINED AN INVESTIGATION. CUSTOMER REPORTED THAT THEIR INTERNAL INVESTIGATION IDENTIFIED THE CAUSE OF THE OVER INFUSION AS AN ISSUE WITH THE MEMBRANE FRAME ASSEMBLY. THE MEMBRANE FRAME ASSEMBLY WAS REPLACED ON THIS DEVICE AND NO ADD'L EVENTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON OVER INFUSION OF PROTONIX. STATED A 200 ML BAG OF PROTONIX INFUSED IN 6 HOURS INSTEAD OF THE INTENDED 12 HOURS. NO PT HARM REPORTED AND NO MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN UNK