BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 188297 · Received September 18, 1998

    Report

    Report Number
    2921482-1998-00143
    Event Type
    Malfunction
    Date Received
    September 18, 1998
    Date of Event
    August 1, 1998
    Report Date
    August 18, 1998
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MEA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF "DEVICE DELIVERING PCA DOSES WITHOUT PUSHING THE BOLUS BUTTON." THE PUMP WAS SET TO INFUSE MEPERIDINE 10MG/ML, 10MG PCA DOSE WITH A 10 MINUTE PT LOCKOUT AD A 300MG 4 HR LIMIT. A NURSE REPORTS THAT "WHEN THE CORD TO THE PT WAS MOVED IT MADE THE PUMP DELIVER MEDICINE. I SHOVED THE CORD ON BACK OF THE PUMP AND A DOSE OF MEDICINE WAS DELIVERED TO THE PT WHILE I WATCHED." THE NURSE REPORTS OBSERVING TWO SELF DELIVERIES. WHEN SHE ASKED THE PT ABOUT THE PUMP, "THE PT TOLD ME IT HAD HAPPENED ALL NIGHT." THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. NO SIGNS OR SYMPTOMS OF OVERSEDATION OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE NURSE DID NOT KNOW THE TOTAL NUMBER OF DOSES DELIVERED OR HOW MANY DOSES WERE REQUESTED BY THE PT. THE PUMP WAS SWITCHED OUT. NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA PLUS INFUSER INFUSION PUMP MEA ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other