BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-PCA II

    MDR report key: 625 · Received May 21, 1992

    Report

    Report Number
    625
    Event Type
    Malfunction
    Date Received
    May 21, 1992
    Date of Event
    March 21, 1992
    Report Date
    May 1, 1992
    Manufacturer
    PHARMACIA-DELTEC, INC.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    AT 0630 NURSE IN TO SEE PATIENT. PUMP DROPPED FROM TABLE AND WAS SWINGING ON TUBING. PUMP BEGAN TO MAKE BUZZING NOISE. NOISE WOULDN'T STOP. BATTERY WAS REMOVING AND REPLACED IN MACHINE BUZZING STOPPED. AND SEEMED TO BE FUNCTIONING PROPERLY. PATIENT WAS AWAKE 0 PAIN AND TALKING TO NURSE. (THE BUZZING WAS THE SAME SOUND AS WHEN PUMP IS PUMPING). 0635 - NURSE RETURNED TO DO BLOOD SUGAR, PATIENT WAS UNRESPONSIVE, NOISY RESP. DIAPHORETIC, INCONTENANCE OF URINE. HELP WAS CALLED. NARCAN GIVEN. PATIENT BEGAN TO ARISEDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAR-91. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD-PCA II PCA CADD PUMP FOR NARCOTIC ADMINISTRATION MEA PHARMACIA-DELTEC, INC. 5800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other