BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 2140730 · Received June 15, 2011

    Report

    Report Number
    2016493-2011-00372
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    May 16, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER STATES THAT PRODUCT WILL NOT BE RETURNED BECAUSE, THE DEVICE HAS BEEN REPAIRED AND PUT BACK INTO SERVICE WITHIN THE HOSPITAL. UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT WAS BEING TRANSFERRED TO THE OPERATING ROOM FROM THE INTENSIVE CARE UNIT WITH INSULIN, VASOPRESSIN, NOREPINEPHRINE AND EPINEPHRINE INFUSING. THE PUMP'S BATTERY DIED DESPITE BEING PLUGGED INTO A WALL UNIT IN THE ICU BEFORE THE TRANSPORT. DRIPS WERE SWITCHED TO ANOTHER SYSTEM. THE CUSTOMER IS CONCERNED THAT THE PUMPS FAIL DUE TO THE BATTERY'S INABILITY TO HOLD A CHARGE. THEY REPORTED THAT THE BATTERY INDICATOR ON THE FRONT OF THE PUMPS GETS LESS AND LESS RELIABLE AS THE BATTERY GOES THROUGH NUMEROUS CHARGE AND DISCHARGE CYCLES. BATTERIES ARE BETWEEN 30-36 MONTHS OF AGE. THERE WAS NO PATIENT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATES THAT NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PC UNIT FRN CAREFUSION CORPORATION 8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN