BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALINES ARTERIAL AND VENOUS BLOOD TUBING SET

    MDR report key: 1222111 · Received November 5, 2008

    Report

    Report Number
    2919260-2008-00001
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 4, 2008
    Report Date
    October 6, 2008
    Manufacturer
    MEDISYSTEMS CORP.
    Product Code
    FJK
    PMA / PMN Number
    K080807
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING AT THE TIME OF SUBMITTING INITIAL MDR. A FOLLOW UP MDR WILL BE FILED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS ONE INCIDENT OF A SEPARATION BETWEEN THE MAIN ARTERIAL TUBING AND THE PUMP SEGMENT CONNECTOR. THE PATIENT'S BLOOD WAS NOT RETURNED RESULTING IN EBL = 300CC. NO PATIENT INJURY OR NEED OR MEDICAL INTERVENTION IS REPORTED. THE COMPLAINT SAMPLE HAS BEEN RETURNED AND INVESTIGATION IS PENDING. THIS REPORT IS BEING FILED AS AN ADVERSE EVENT SOLELY TO COMPLY WITH THE FDA'S BLOOD LOSS POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALINES ARTERIAL AND VENOUS BLOOD TUBING SET HEMODIALYSIS BLOOD TUBING SET FJK MEDISYSTEMS CORP. NA 8055402

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other