BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA

    MDR report key: 2929910 · Received January 14, 2013

    Report

    Report Number
    2929910
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    November 2, 2012
    Report Date
    January 14, 2013
    Manufacturer
    CURLIN MEDICAL
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    NURSE RETRIEVED DATA FROM PCA DURING HER SHIFT. MEDICATION DOSE WAS 0.3 MG, PER PATIENT SELF-ADMINISTERED BOLUS. AT NOON, THE MACHINE REPORTED AMT 0.4 MG (AMOUNT GIVEN), BG (BOLUS GIVEN) 1, BA (BOLUS ATTEMPT) 0. TWELVE HOURS LATER, AMT 0.6 MG, BG 1, BA 2. COMPUTED AMOUNT GIVEN DOES NOT ADD UP CORRECTLY BASED ON BOLUS GIVEN TO PATIENT. CONFIRMED TOTAL AMOUNT GIVEN ON THIS MACHINE WAS CORRECT (87 BOLUS WERE GIVEN AT 0.3 MG = 26 MG ADMINISTERED). NO PATIENT HARM.CLINICAL ENGINEERING COMPLETED AN EVALUATION ON THE PUMP AND COULD NOT DUPLICATE THE PROBLEM. ALSO VERIFIED OPERATION AND PERFORMED VOLUMETRIC ACCURACY TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21124 PCA PUMP, INFUSION, PCA MEA CURLIN MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR NO OTHER THERAPIES