BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPUMP PAIN MANAGEMENT SYSTEM

    MDR report key: 427888 · Received November 12, 2002

    Report

    Report Number
    6000001-2002-05287
    Event Type
    Injury
    Date Received
    November 12, 2002
    Date of Event
    October 9, 2002
    Report Date
    October 16, 2002
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE FACILITY'S NURSE PRACTITIONER REPORTED AN INFUSION PUMP THAT WAS INVOLVED WITH A PATIENT REACTION DURING USE. IN 2002, 16 HOURS POST OPERATION FOR BOWEL RESECTION FOR DIVERTICULITIS, A PATIENT WAS FOUND UNRESPONSIVE AND FLAT-LINE ON CARDIAC MONITOR. THE PATIENT CARDIAC RHYTHMN WAS RE-ESTABLISHED, BUT THE PATIENT REMAINS UNRESPONSIVE. THE PATIENT REMAINS MECHANICALLY VENTILATED AT THIS TIME. THE CLINICAN REPORTS TO THE BEST OF THEIR KNOWLEDGE PUMP WAS PROGRAMMED CORRECTLY. SHE STATES THE CAUSE OF THE PATIENT'S CARDIAC ARREST REMAINS UNKNOWN. THE PATIENT WAS RECEIVING A SOLUTION OF MARCAINE 0.1% AND FENTANYL 3 MICROGRAMS PER ML IN A TOTAL VOLUME OF 223 ML. THE PUMP WAS SET TO DELIVER A BASAL RATE OF 7 ML/HR, USING 2L3512 EPIDURAL TUBING. DURING A FOLLOW-UP PHONE CALL TO THE NURSE PRACTITIONER ON 11/11/2002, IT WAS LEARNED THAT THE PATIENT EXPIRED (DATE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPUMP PAIN MANAGEMENT SYSTEM PCA PUMP MEA BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death 2L3512, EPIDURAL PUMP SET.