BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENOUS BLOODLINE FOR FRESENIUS 2008

    MDR report key: 373901 · Received January 24, 2002

    Report

    Report Number
    8030665-2001-00076
    Event Type
    Death
    Date Received
    January 24, 2002
    Date of Event
    December 27, 2001
    Report Date
    December 28, 2001
    Manufacturer
    REYNOSA MANUFACTURING
    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

    FACILITY REPORTS THAT THREE HOURS INTO THE TREATMENT, THE VENOUS BLOODLINE HAD COMPLETELY DISCONNECTED FROM THE PATIENT'S TESIO CATHETER. PATIENT CONNECTOR CLIP WAS BEING USED AT THE TIME OF THE INCIDENT AND BLOODLINE AND CATHETER HAD DISCONNECTED WITHIN THE CLIP. ACCESS CHECKS WERE DOCUMENTED AS BEING DONE EVERY THIRTY MINUTES. ACCESS WAS UNCOVERED. MACHINE DID NOT ALARM. 160 NARROW VENOUS LIMITS SOFTWARE WAS ENGAGED. EBL-400CC. PATIENT WAS SENT TO E.R. AND SUBSEQUENTLY HAD A HEART ATTACK AND EXPIRED. VENOUS BLOODLINE AND PATIENT CONNECTOR CLIP ARE AVAILABLE FOR EVALUATION. QUESTIONNAIRE FOR DISCONNECTS AND BLOODLINE DISINFECTION PROCEDURE FAXED TO UNIT. 01/02 UPDATE THE D.O.N UPON FURTHER REVIEW OF THE INCIDENT WITH STAFF IT HAS BEEN DETERMINED THAT THE MACHINE DID ALARM DURING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE FOR FRESENIUS 2008 HEMODIALYSIS DEVICE FKJ REYNOSA MANUFACTURING NA 1NR052

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death 2008H, VENOUS BLOODLINE FOR FRESENIUS 2008.