BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUEST 521

    MDR report key: 5913 · Received March 15, 1993

    Report

    Report Number
    5913
    Event Type
    Malfunction
    Date Received
    March 15, 1993
    Date of Event
    February 19, 1993
    Report Date
    February 23, 1993
    Manufacturer
    INTELLIGENT PUMP VARIABLE PRESSURE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED 6 MGM BOLUS TPA IN THE ED 94 MGM HUNG & CONNECTED TO QUEST PUMP, PATIENT WAS TRANSFERRED TO THE WRONG CARE UNIT. AT BEGINING OF 3RD TPA DOSE THERE WAS 40 MGM REMAINING IN BAG, PATIENT HAD RECEIVED 60 MGM OF THE 100 MGM ORDERED. QUEST PUMP DID NOT DELIVER SET RATE AND DID NOT ALARM. PATIENT COMPLAINED OF INCREASED CHEST PAIN AND EKG SHOWED HIGHTER ST SEGMONTS LATERALLY. PATIENT WAS IN A CARDIO SYSTEMS BED RECEIVING IV LIDO ON QUEST PUMP IV HEPIN ON QUEST PUMP, BEING MONITORED WITH SPACE LAP MONITORDEVICE 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-FEB-93. SERVICE PROVIDED BY: INDEPENDENT SERVICE ORGANIZATION. 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, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUEST 521 IV. PUMP FRN INTELLIGENT PUMP VARIABLE PRESSURE N-104923 900328

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other