BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESENIUS

    MDR report key: 6626 · Received September 20, 1993

    Report

    Report Number
    2243621-1993-00114
    Event Type
    Malfunction
    Date Received
    September 20, 1993
    Date of Event
    July 26, 1993
    Report Date
    August 9, 1993
    Manufacturer
    FRESENIUS
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ULTRA FILTRATION PRE U F PUMP GOT DISCONNECTED DDURING TREATMENT. PATIENT LAST 3.5 KILS AFTER 1.5 LITER REPLACEMENT. MACHINE PROGRAMMED TO LASE 1.5 KILOS. PRESSURE TEST WAS DONE PRE-TREATMENT (LARGE AMOUNT OF FLUID NOTICED ON FLOOR).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-JUL-93. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, NONE OR UNKNOWN, OTHER. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS MACHINE KDI FRESENIUS 2008E

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other