BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIT-LINE BLOOD CHAMBER

    MDR report key: 3823813 · Received February 20, 2014

    Report

    Report Number
    2937457-2014-00263
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 18, 2014
    Report Date
    January 20, 2014
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KOC
    PMA / PMN Number
    K935958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS INPATIENT USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE CHIEF TECH STATED THAT THE BOX WAS NOT DAMAGED, BUT THE CRIT-LINES WERE LEAKING FROM THE WINDOW WHERE THEN SENSOR SNAPS ON AND THAT THERE WAS A WEAKNESS WHERE YOU TIGHTEN IT IN TO THE DIALYZER. TECH STATED THAT THERE IS A LINE ON THE AREA AND WHEN TIGHTENED IT IN TO THE DIALYZER. TECH STATED THAT THERE IS A LINE ON THE AREA AND WHEN TIGHTENED IT SNAPS AND LEAKS. THE LEAK WAS VISUALLY OBSERVED. ESTIMATED BLOOD LOSS WAS 200CC'S. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106712 CRIT-LINE BLOOD CHAMBER KOC CONCORD MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 PHOENIX GAMBRO HEMODIALYSIS MACHINE