BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IVAC INFUSION PUMP

    MDR report key: 3017 · Received September 2, 1992

    Report

    Report Number
    3017
    Event Type
    Injury
    Date Received
    September 2, 1992
    Date of Event
    January 18, 1992
    Report Date
    January 31, 1992
    Manufacturer
    IVAC
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DEVICE - IVACE INFUSION PUMP PLE BRACKET.THE PATIENT WS PUSHING THE INFUSION PUMP WHICH WA ATTACHED TO THE POLE WITH AN IVAC INFUSION PUMP BRACKET. THE HANDLE ON THE POLE BROKE AND THE PATIENT FELL TO THE FLOOR. SHE ENCOUNTERED PAIN TO HER RIGHT SHOULDER. X-RAYS REVEALED NO FRACTURES. A SLING WAS APPLIED TO HER ARMDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. 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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVAC INFUSION PUMP INFUSION PUMP BRACKET FRN IVAC 124309

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention