BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM COMBI SET

    MDR report key: 6205899 · Received December 27, 2016

    Report

    Report Number
    8030665-2016-00639
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 27, 2016
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE BLOODLINE WAS SUBJECTED TO A LABORATORY LEAK TEST WHERE A LEAK, OBSERVED AS A STEADY FLOW OF BUBBLES, WAS IDENTIFIED FROM THE PUMP TUBING TO THE RED ¿T¿ ADAPTER. THE SAMPLE WAS SUBMERGED INTO WATER WITH AIR PRESSURE INCREASING TO 20 PSI FOR A PERIOD OF TEN MINUTES. THE SAMPLE WAS FURTHER INSPECTED WHERE THE COMPLAINT INVESTIGATOR OBSERVED A DRYNESS CHANNEL AT THE JOINING OF THE PUMP TUBING TO THE RED ¿T¿ ADAPTER. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THE LOT PASSED ALL RELEASE CRITERIA. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS ABLE TO CONFIRM THE FAILURE MODE. SUBMERSION OF THE TUBING IN A WATER BATH NOTED A STEADY FLOW OF BUBBLES FROM THE PUMP TUBING TO THE RED ¿T¿ ADAPTER. THEREFORE, THE COMPLAINT HAS BEEN DEEMED CONFIRMED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A BLOOD LEAK OCCURRED APPROXIMATELY 1 HOUR AFTER INITIATION OF THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING A BLOODLINE TUBING LEAK. THE MACHINE DID NOT ALARM AS IT IS NOT INTENDED TO DO SO. BLOOD WAS VISUALLY OBSERVED LEAKING EXTERNALLY FROM THE BLOODLINE AT THE JUNCTION OF THE HEPARIN ADMINISTRATION LINE WHERE IT CONNECTS TO THE BLOOD PUMP SEGMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 20 CC. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT COMPLETED TREATMENT WITH A NEW SET-UP ON THE SAME MACHINE. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856114 CUSTOM COMBI SET SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK ERIKA DE REYNOSA, S.A. DE C.V. 16KR01456

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR FRESENIUS 2008T HEMODIALYSIS MACHINE| OPTIFLUX F180NRE DIALYZER FINISHED ASSY.