BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I.V. PUMP

    MDR report key: 9007 · Received July 29, 1994

    Report

    Report Number
    9007
    Event Type
    Malfunction
    Date Received
    July 29, 1994
    Date of Event
    June 9, 1994
    Report Date
    June 20, 1994
    Manufacturer
    3M/AVI
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED OVER-INFUSION OF ZANTAC FROM MALFUNCTION OF AVI I.V. PUMP. XRAY ORDERLY TRANSPORTING PATIENT TO RADIOLOGY UNPLUGGED PUMP FROM WALL OUTLET WITHOUT PLACING UNIT IN "STANDBY" MODE. PUMP DISPLAY WENT TO ALL "8'S". UNKNOWN AS TO WHETHER DEVICE WAS IN STANDBY MODE AFTER DISPLAY WENT TO ALL "8'S".DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-APR-94. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: ELECTRICAL PROBLEM, INCORRECT TECHNIQUE/PROCEDURE, BATTERY/PACK, POWER SUPPLY. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED, INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I.V. PUMP I.V. PUMP 3M/AVI 200

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other