BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 287711 · Received July 24, 2000

    Report

    Report Number
    8030665-2000-00224
    Event Type
    Malfunction
    Date Received
    July 24, 2000
    Date of Event
    June 13, 2000
    Report Date
    June 29, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FMC PRODUCT COMPLAINT RECEIVED. STATED COMPLAINT IS "AFTER 15 MINUTES OF TREATMENT (DIALYSIS), BLOOD WAS NOTED ON THE FLOOR, APPROXIMATELY 50CC. MACHINE WAS TURNED OFF (BLOOD PUMP) AND LINES WERE CHECKED FOR HOLES. WHEN THE MACHINE WAS TURNED ON AGAIN, BLOOD WAS NOTED COMING FROM THE VENOUS LINE NEAR THE VENOUS PORT". WILL CALL FACILITY TO VERIFTY WHETHER "VENOUS PORT" WAS INLINE INJECTION PORT OF THE VENOUS DRIP CHAMBER, AND STATUS OF SAMPLE AVAILABITY. MDR WILL BE FILED FOR REPORTED BLOOD LOSS. 7/14/00 FACILITY CALLED TO REQUEST SAMPLE AVAILABILITY. 7/24/2000 USER FACILITY REPORTED THAT THE COMPLAINT SAMPLE HAS BEEN LOCATED AND WILL BE FORWARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE NON-MACHINE SPECIFIC BLOODLINE TUBING FOR HEMODIALYSIS FKJ ERIKA DE REYNOSA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other HEMODIALYSIS 6/29/2000