BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIT-LINE BLOOD CHAMBER

    MDR report key: 3950855 · Received June 13, 2014

    Report

    Report Number
    2937457-2014-01030
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 16, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KOC
    PMA / PMN Number
    K935958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER HOWEVER, A COMPANION SAMPLE FROM THE SAME LOT IS AVAILABLE FOR RETURN. PLANT INVESTIGATION IS PENDING THE RECEIPT OF THE COMPANION SAMPLE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED UPON THE COMPLETION OF THE INVESTIGATION. SEE RELATED MDRS: 2937457-2014-01023, 2937457-2014-01024, 2937457-2014-01025, 2937457-2014-01026, 2937457-2014-01027, 2937457-2014-01028, 2937457-2014-01029, 2937457-2014-01030, 2937457-2014-01031, 2937457-2014-01032, 2937457-2014-01033 AND 2937457-2014-01034.

    Description of Event or Problem · 1

    A PATIENT CARE TECHNICIAN REPORTS DEVICES WERE LOOSENING DURING TREATMENT WHICH ALLOWED A SMALL AMOUNT OF BLOOD TO LEAK. UPON FOLLOW UP WITH THE FACILITY CLINICAL MANAGER SHE REPORTS THIS FACILITY HAS STAFF VERY EXPERIENCED WITH THE PRODUCT AND NOTED RECENTLY THE OCCURRENCES OF BLOOD LEAKING FROM THE AREA WHERE THE CHAMBER CONNECTS TO THE DIALYZER. THE CONNECTION WAS TIGHTENED PRIOR TO THE BEGINNING OF TREATMENT AND APPEARS TO LOOSEN OVER TIME LEADING TO A LEAK OF BLOOD. THE DEVICES WERE RE-TIGHTENED DURING TREATMENT AND THE TREATMENTS COMPLETED. EBL <5ML. THERE WERE NO PATIENT ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. PATIENT IDENTIFIERS ARE NOT AVAILABLE. THE ACTUAL SAMPLES WERE DISCARDED. COMPANION SAMPLE IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351264 CRIT-LINE BLOOD CHAMBER KOC FRESENIUS MEDICAL CARE NORTH AMERICA 131114

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS DIALYSIS MACHINE| FRESENIUS ACID & BICARB PRODUCT| FRESENIUS COMBISET BLOODLINES| FRESENIUS DIALYZER| FRESENIUS SALINE