BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 279618 · Received May 25, 2000

    Report

    Report Number
    8030665-2000-00176
    Event Type
    Injury
    Date Received
    May 25, 2000
    Date of Event
    April 27, 2000
    Report Date
    May 5, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PRODUCT COMPLAINT RECEIVED BY MAIL FROM FMC CLINIC. EVENT REPORTED AS "SYSTEM SEPARATION" OF VENOUS LINE TO CATHETER. FURTHER INFO RECEIVED FROM MEDCOMP, AS THEY WERE NOTIFIED AS THE MFR OF THE CATHETER. DISCONNECTION OF PT LUER OF VENOUS BLOODLINE FROM VENOUS LIMB OF ASH SPLIT CATHETER FOUND 20 MINUTES INTO HEMODIALYSIS TREATMENT. ESTIMATED BLOOD LOSS REPORTED AS >100CC. ACCORDING TO INFO RECEIVED THE PT REMAINED STABLE WITH THE BLOOD LOSS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE CATHETER WAS INSPECTED BY THE NURSES FOR ANY OBVIOUS DEFECT OR DAMAGE. AS REPORTED, SINCE NO ABNORMALITIES WERE SEEN, THE CATHETER WAS LEFT IN AND IS IN CONTINUED USE WITHOUT FURTHER INCIDENT. RN, D.O.N. PROVIDED FURTHER INFO WITH QUALITY SURVEY QUESTIONNAIRE. BLOOD LOSS REPORTED MORE SPECIFICALLY AS 400-500CC. BLOOD PRESSURE STABLE AT 154/75. CATHETER WAS COVERED WITH PT'S BLANKET. COMPLAINT BLOODLINE IS AVAILABLE FOR EVAL. LOT NUMBER IS NOT AVAILABLE. BLOOD FLOW RATE 400ML/MIN AND VENOUS PRESSURE PRE INCIDENT WAS 160. THE MACHINE DID NOT ALARM. THE EVENT OCCURRED 20 MINUTES INTO TREATMENT.

    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 Other FRESENIUS 2008H DIALYSIS MACHINE.| ASH SPLIT CATHETER (MEDCOMP) INSERTED 1999,