BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-DAK 3500

    MDR report key: 5736 · Received April 29, 1993

    Report

    Report Number
    2243621-1993-00049
    Event Type
    Injury
    Date Received
    April 29, 1993
    Date of Event
    February 9, 1993
    Report Date
    March 12, 1993
    Manufacturer
    C.D. MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    UNIT ALLEGES A BLOOD LEAK ON FIRST USE WET PACK DIALYZER. UPON INITIATION OF HEMODIALYSIS, BLOOD WAS NOTICED ON DRAIN LINE. TREATMENT STOPED; SYSTEM DISCARDED. ESTIMATED BLOOD LOSS 250CC. NO MEDICAL INTERVENTION REQUIRED, PER HCPDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-DAK 3500 HEMODALYZER KDI C.D. MEDICAL, INC. 3500 732622B1Y

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other