BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS BLOODLINE FOR FRESENIUS 2008

    MDR report key: 291288 · Received August 17, 2000

    Report

    Report Number
    8030665-2000-00261
    Event Type
    Injury
    Date Received
    August 17, 2000
    Date of Event
    July 29, 2000
    Report Date
    August 9, 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
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    "QS" NOTIFIED FRESENIUS MEDICAL CARE "DSD" OF THIS PT EVENT. THE REPORTED EVENT WAS A VENOUS BLOODLINE DISCONNECT FROM A TESIO CATHETER AT THE START OF THE TREATMENT. BLOOD LOSS REPORTED AS 250CC. NO VENOUS PRESSURE ALARMS SOUNDED AFTER THE DISCONNECTION. THE RN REPORTED THAT THE EVENT OCCURRED FROM NOT PROPERLY MAKING THE CONNECTION". THERE WERE NO ADVERSE AFFECTS WITH THE PT AND THE INCIDENT, ACCORDING TO THE INFORMATION PROVIDED. TWO UNITS OF BLOOD WERE GIVEN. DO NOT KNOW IF TRANSFUSION RELATED DIRECTLY TO THE EVENT. "QS" CALLED RN WHO STATED SHE COULD LOCATE THE BLOODLINE PACKAGE AND LOT NUMBER. ALSO PT WAS GIVEN BLOOD AS A RESULT OF THE BLOOD LOSS AND EVENT. PT WAS STABLE FOLLOWING EVENT. ACTUAL SAMPLE WAS DISCARDED AS TREATMENT TOOK PLACE AT HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE FOR FRESENIUS 2008 BLOODLINE TUBING FOR HEMODIALYSIS FKJ ERIKA DE REYNOSA NA 0CR003

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other FRESENIUS 2008H W/NVL SOFTWARE/MEDCOMP ASH SPLIT| CATHETER PLACED 07/20/2000.