BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD AMBULATORY PCA PUMP

    MDR report key: 4132 · Received July 20, 1992

    Report

    Report Number
    4132
    Event Type
    Malfunction
    Date Received
    July 20, 1992
    Date of Event
    February 12, 1992
    Report Date
    March 3, 1992
    Manufacturer
    BARD
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    MORPHINE SULFATE VIA PCA PUMP INITIATED. PHYSICIAN'S ORDER READ CONTINUOUS RATE 0.5 MG./HR. PCA DOSE A MG Q 3 HR. TOTAL 2.5 MG Q3 HR. PUMP PROGRAMMED FOR CONTINUOUS RATE 1 MG/HR PCA DOSE 0.5 MG Q3 H. TOTAL 2 MG/HR. 12 HOURS AFTER PUMP ORIGINALLY PROGRAMMED, ERROR DETECTED AND CORRECTED. PATIENT'S CONDITION REMAINED STABLEDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-SEP-91. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INCORRECT TECHNIQUE/PROCEDURE. CONCLUSION: USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE DISCARDED, DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR, INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD AMBULATORY PCA PUMP PATIENT CONTROLLED ANALGESIA PUMP MEA BARD 6464202 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other