BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROVIDER PAIN MANAGEMENT PUMP

    MDR report key: 280108 · Received May 26, 2000

    Report

    Report Number
    2024064-2000-00044
    Event Type
    Other
    Date Received
    May 26, 2000
    Date of Event
    May 1, 2000
    Report Date
    May 11, 2000
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM ABBOTT INTERNATIONAL AFFILIATE (ABBOTT AUSTRALIA) REPORTING AN OVERDELIVERY RELATED TO PATIENT TAMPERING. THE REPORT STATES: "A PATIENT WAS RECEIVING AN IV PCA INFUSION VIA THE APM. WHEN THE NURSING STAFF CHECKED THE HISTORY IT WAS FOUND THAT PT HAD ACUTALLY RECEIVED SOME "LOADING DOSES" WHICH WERE NOT PRESCRIBED BY THE MEDICAL STAFF, NOR DELIVERED BY THE NURSING STAFF. THE NURSES THOUGHT IT MAY HAVE BEEN A MALFUNCTION OF THE APM SO DECIDED TO CHANGE THE PUMP. HOWEVER, LATER IN THE DAY IT WAS AGAIN DISCOVERED THAT MORE "LOADING DOSES" HAD BEEN ADMINISTERED. IT TRANSPIRED THAT THE PATIENT HAD DISCOVERED HOW TO REMOVE THE KEYPAD LOCK AND GIVE THEMSELF THE FOLLOWING MORNING BEFORE THE INCIDENT COULD BE INVESTIGATED. "THERE WAS NO PRESCRIPTION INFORMATION AVAILABLE. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVIDER PAIN MANAGEMENT PUMP INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other