BEUDAMED
    FDA Adverse Event Summary report: N

    LUNDIA IC 6N PARALLEL PLATE DIALYZER

    MDR report key: 9864 · Received August 11, 1993

    Report

    Report Number
    9864
    Date Received
    August 11, 1993
    Date of Event
    April 16, 1993
    Report Date
    July 28, 1993
    Manufacturer
    CGH MEDICAL
    Product Code
    FJG
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    4/16/93 EARLY INTO TREATMENT, AFTER PASSING PRE PRESSURE TESTS, BLOOD WAS NOTED TO BE LEAKING FROM SIDE OF DIALYZER. APX. BLOOD LOSS < 50MLS, UNABLE TO RETURN REMAINED OF BLOOD FOR TOTAL LOSS OF APX. 300MLS. THERE WAS NO CHANGE IN THE HCT. THE PATIENT WAS NOT SYMPTOMATIC & DID NOT REQUIRE TRANSFUSION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID 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 LUNDIA IC 6N PARALLEL PLATE DIALYZER FJG CGH MEDICAL 3-0512-N-11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Invalid Data