BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOME HEMO COMBI SET

    MDR report key: 6084050 · Received November 7, 2016

    Report

    Report Number
    8030665-2016-00558
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 13, 2016
    Report Date
    November 7, 2016
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FJK
    PMA / PMN Number
    K070049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT IS NOT CONFIRMED AS THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR MANUFACTURER EVALUATION. AS SUCH, A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE. 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. REVIEW OF THE BATCH PRODUCTION RECORD (BPR) DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT.

    Description of Event or Problem · 1

    A PATIENT REPORTED OBSERVING AIR BUBBLES IN THE BLOODLINE NEAR THE ARTERIAL CHAMBER. THE EVENT OCCURRED APPROXIMATELY 3 HOURS INTO THE PATIENT'S HOME HEMODIALYSIS (HD) TREATMENT. THE PATIENT ENDED TREATMENT AND STARTED TO DO A MANUAL RETURN OF HIS BLOOD. THE PATIENT WAS ABLE TO RETURN APPROXIMATELY 3/4 OF THE BLOOD WITHIN THE EXTRACORPOREAL CIRCUIT. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 1/4 OF THE BLOOD THAT WAS LEFT IN THE CIRCUIT. THE PATIENT INDICATED THAT NO AIR WAS VISIBLE IN THE VENOUS RETURN LINE. THE MACHINE ALARMED FOR AIR APPROPRIATELY. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. NO BLOODLINE DAMAGE WAS VISIBLE. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISCARDED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734064 HOME HEMO COMBI SET SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK ERIKA DE REYNOSA, S.A. DE C.V. 16AR01291

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR FRESENIUS K@HOME HEMODIALYSIS MACHINE