BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVIDER PAIN MANAGEMENT PUMP

    MDR report key: 335522 · Received May 25, 2001

    Report

    Report Number
    2024064-2001-00043
    Event Type
    Malfunction
    Date Received
    May 25, 2001
    Date of Event
    March 25, 2001
    Report Date
    April 26, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM ABBOTT INT'L AFFILIATE (ABBOTT FRANCE) OF AN OVER-DELIVERY. THE REPORT STATES: "AFTER SURGERY (HYSTERECTOMY) THE PUMP WAS USED WITH MORPHINE IN BOLUS MODE. THE PUMP DIDN'T STOP INFUSING AFTER INFUSION OF 1MG BOLUS. THE PT CALLED THE NURSE AND THE PUMP HAS BEEN DISCONNECTED. THE PT DID NOT EXPERIENCE ANY ADVERSE EVENT." THE ABBOTT INT'L AFFILIATE WAS QUERIED FOR FURTHER INFO. IT WAS REPORTED THAT THE PUMP WAS PROGRAMMED TO INFUSE 1MG/BOLUS DOSE. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE PT. THERE WAS NO REPORTED ADVERSE EVENT WITH THE PT. NO ADD'L NFO HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24576 PROVIDER PAIN MANAGEMENT PUMP INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other