BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS

    MDR report key: 23080 · Received February 4, 1994

    Report

    Report Number
    23080
    Event Type
    Injury
    Date Received
    February 4, 1994
    Date of Event
    September 23, 1993
    Report Date
    October 1, 1993
    Manufacturer
    FRESENIUS USA
    Product Code
    KPO
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    1 HR INTO TREATMENT, PT C/O NAUSEA AND OI DISTRESS, PT'S TX DLC'D AND THEN RESTARTED 1 HOUR LATER. PT AGAIN C/O NAUSEA, CHILLS, TINGING OF BODY AND GENERALIZED BARE PAINS, PT FELT LIGHTHEADED, VSS, TX TERMINATED, SYMPTOMS VESDUED 20 MINUTES LATER, PT SENT HOME NEXT SHIFF, NEW PATIENT PUT ON MACHINE (SEE MDR) AND BECAME SYMPTOMATIC IN MOMENTS, TREATMENT TERMINATED MACHINE PULLED.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 2.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: 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 FRESENIUS HEMODIALYSIS MACHINE KPO FRESENIUS USA A2008

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other