BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVI

    MDR report key: 8218 · Received July 21, 1994

    Report

    Report Number
    8218
    Event Type
    Injury
    Date Received
    July 21, 1994
    Date of Event
    February 25, 1994
    Report Date
    March 9, 1994
    Manufacturer
    3M HEALTH CARE
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PT. RECEIVING D175 HYPERALIMENTATION AT 3CC/HR. PUMP FOUND WITH RATE DISPLAYED A 110CC/HR. APPROXIMATELY 70CC HAD BEEN INFUSED IN ABOUT ONEHOUR. RATE CHANGES TO 3CC, BY NURSE AND PUMP RATE AGAIN CHANGED TO 110CC/HR WITHIN 2 MINUTES. IV DISCONTINUED, VENT PRESSURE AND RATE INCREASED, BLOOD SUGARS ELEVATED TO 1000, IV INSULIN GIVEN. PATIENT'S BLOOD SUGARS AND RESPIRATORY STATUS STABILIZED WITHIN 24 HOURS. NO PERMANENT OR LONG LASTING EFFECTS KNOWN AT THIS TIME.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-NOV-93. 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, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVI INFUSION PUMP FRN 3M HEALTH CARE 400

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other