BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS HOLLOW FIBER DIALYZER

    MDR report key: 308202 · Received November 22, 2000

    Report

    Report Number
    9681863-2000-00003
    Event Type
    Malfunction
    Date Received
    November 22, 2000
    Date of Event
    October 25, 2000
    Report Date
    November 22, 2000
    Manufacturer
    SECON, ZNL DER GAMBRO / DIALYSATOREN GMBH&CO. KG
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EXTERNAL BLOOD LEAK DURING DIALYSIS TREATMENT OCCURED. CUSTOMER REPORTED THAT THE ARTERIAL PART OF THE DIALYZER HEADER WAS CRACKED. THE CRACK WAS NOTICED AS SOON AS DIALYSIS TREATMENT WAS INITIATED. BLOOD OF THE EXTRACORPORAL CIRCUIT WAS RETURNED TO PT. NO PT INJURY OCCURED. NO INTERVENTION REQUIRED. A NEW SYSTEM WAS SETUP WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CS HOLLOW FIBER DIALYZER HOLLOW FIBER DIALYZER FJI SECON, ZNL DER GAMBRO / DIALYSATOREN GMBH&CO. KG NA G06E5073

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other