BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOME HEMO COMBI SET

    MDR report key: 6086128 · Received November 8, 2016

    Report

    Report Number
    8030665-2016-00559
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Report Date
    November 8, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS NOT CONFIRMED AS THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR MANUFACTURER EVALUATION. NO FURTHER TESTING WAS DONE ON A COMPANION SAMPLE AS THE ENTIRE LOT HAS BEEN SOLD AND DISTRIBUTED. AS SUCH, A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE ACTUAL 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 NON-CONFORMANCES OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. IN ADDITION, THE LOT PASSED ALL IN-PROGRESS AND FINAL QC TESTING AND PASSED ALL RELEASE CRITERIA. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO CONFIRM THE FAILURE MODE. REVIEW OF THE BATCH PRODUCTION RECORD (BPR) DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. THEREFORE, THE COMPLAINT HAS BEEN DEEMED UNCONFIRMED.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING A HOME HEMODIALYSIS (HD) PATIENT'S TREATMENT, THE PATIENT REPORTEDLY OBSERVED AIR BUBBLES IN THE BLOOD LINES. FOLLOW-UP WITH THE PATIENT CONFIRMED THAT SOMETIME BEFORE THE MONTH OF (B)(6), THE 2008K@HOME MACHINE ALARMED FOR AIR DETECTED APPROXIMATELY 3/4 OF TIME INTO THE HD TREATMENT. THE PATIENT HAD ENDED TREATMENT AND STARTED TO DO A MANUAL RETURN OF HIS BLOOD. THE PATIENT WAS ABLE TO RETURN 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 DID NOT SET UP WITH NEW SUPPLIES TO COMPLETE THE REST OF TREATMENT. THE PATIENT WAS ABLE TO SUCCESSFULLY COMPLETE HIS NEXT SCHEDULED TREATMENT. THERE WERE NO PATIENT ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT CONTINUES TO HAVE SUCCESSFUL HOME HD TREATMENTS. NO DAMAGE TO THE BLOODLINE TUBING SET WAS VISIBLE. THE BLOODLINE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER AS IT WAS DISCARDED BY THE PATIENT. THE MACHINE ALARMED FOR AIR APPROPRIATELY. RECENTLY, THE PATIENT'S ASSOCIATED CLINIC SENT A BIOMEDICAL TECHNICIAN TO THE PATIENT'S HOME TO VERIFY THE MACHINE'S OPERATIONAL INTEGRITY. FUNCTIONAL TESTING PERFORMED BY THE BIOMED CONFIRMED THE UNIT WAS OPERATING PROPERLY. THE MACHINE PASSED ALL FUNCTIONAL TESTS AND REMAINS IN USE BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736503 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 FRESENIUS 2008K@HOME HEMODIALYSIS (HD) MACHINE