BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP II PUMP

    MDR report key: 184166 · Received August 20, 1998

    Report

    Report Number
    6000001-1998-00542
    Event Type
    Malfunction
    Date Received
    August 20, 1998
    Date of Event
    February 13, 1998
    Report Date
    July 23, 1998
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 2/13/98, AN INCIDENT OCCURRED WHICH RESULTED IN NO PT OR USER INJURY. IT WAS REPORTD BY THE COMPLAINANT TO BAXTER HEALTHCARE LTD., AND SUBSEQUENTLY TO THE NOTIFIED BODY, AND TO QUALITY MANAGEMENT, I.V. SYSTEMS DIVISION,BAXTER HEALTHCARE CORP. THE REPORT STATED THAT "THE PUMP DISPLAYED THAT 180MLS REMAINING IN EPIDURAL BAG. HOWEVER, ON INSPECTION PUMP READING WAS INCORRECT, THE INFUSION BAG WAS EMPTY. "BAXTER HEALTHCARE LTD. REQUESTED INFO FROM THE HOSP ABOUT THIS COMPLAINT AND WAS UNABLE TO LOCATE OR IDENTIFY THIS PUMP IN ITS SYSTEM. CHECKING WITH REPAIR FACILITY, IT WAS LEARNED THAT THE PUMP WITH THIS SERIAL NUMBER WAS REC'D FOR REPAIR 3/24/98. THERE ARE NO REMARKS IN PAPERWORK INDICATING THE REASON FOR RETURN. PUMP ACCURACY WAS MEASURED AT 1.2% AT 90ML/HR AND OCCLUSION WAS 19.6; RESERVOIR WAS REPLACED. PUMP WAS REC'D AGAIN 5/11/98 AND RESERVIOR REPLACED. SINCE THE PUMP HAD BEEN SERVICED TWICE BETWEEN THE TIME OF THE INCIDENT AND THE TIME THE INCIDENT WAS REPORTED TO BAXTER HEALTHCARE LTD, NO INVESTIGATION COULD BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AP II PUMP PCA PUMP MEA BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA