BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP

    MDR report key: 603598 · Received May 13, 2005

    Report

    Report Number
    2921482-2005-00276
    Event Type
    Malfunction
    Date Received
    May 13, 2005
    Date of Event
    April 23, 2005
    Report Date
    April 25, 2005
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF A DELAY OF CRITICAL THERAPY. AT AN UNSPECIFIED TIME, CHANNEL C WAS PROGRAMMED TO DELIVER 0.2MG/KG/MIN OF "DOUBLE STRENGTH" EPINEPHRINE AT A RATE OF 60ML/HR AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 1500, CHANNEL C SOUNDED AN AUDIBLE ALARM TONE AND THE DELIVERY STOPPED. DURING THE ALARM CONDITION, THE NURSE NOTED THAT THE PT'S SYSTOLIC BLOOD PRESSURE (SBP) DECREASED FROM 115MMHG TO 70MMHG. APPROX TWO MINUTES LATER, THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. AFTER THE THERAPY WAS RESUMED, THE PT'S SFB INCREASED TO 120MMHG. NO MEDICAL INTERVENTION WERE REQUIRED. THERE WERE NO REPORTED ADVERSE PT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP INFUSION PUMP FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other