BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABRATEK 6060 HOMERUN PUMP

    MDR report key: 281145 · Received June 6, 2000

    Report

    Report Number
    6000001-2000-00299
    Event Type
    Malfunction
    Date Received
    June 6, 2000
    Date of Event
    October 1, 1997
    Report Date
    April 27, 2000
    Manufacturer
    BAXTER/SABRATEK CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO LONG-TERM PAIN MANAGEMENT PTS (BOTH CANCER PATIENTS), RECEIVED OVERDOSES OF MORPHINE WHEN ATTEMPTING TO USE THE PCA BUTTON ON THE 6060 PUMPS. THE OVERDOSE WAS CONFIRMED USING MEDIVIEW TECHNOLOGY, ACCORDING TO FACILITY REP; EVEN THOUGH THE PUMP HAD BEEN CORRECTLY PROGRAMMED. FORTUNATELY, THESE PTS WERE OPIOID TOLERANT AND HAD NO SERIOUS LASTING EFFECTS RELATED TO THE OVERDOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABRATEK 6060 HOMERUN PUMP SABRATEK 6060 PUMP FRN BAXTER/SABRATEK CORP. 606000-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN