BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM COMBI SET

    MDR report key: 6167515 · Received December 12, 2016

    Report

    Report Number
    8030665-2016-00610
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 15, 2016
    Report Date
    December 12, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 USER FACILITY REPORTED THAT A BLOOD LEAK OCCURRED IMMEDIATELY AFTER INITIATION OF THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING A BLOODLINE TUBING LEAK AS THE CLAMP TO THE MEDICATION PORT ON THE VENOUS LINE FAILED TO CLAMP TIGHT ENOUGH TO PREVENT BLOOD FROM FLOWING PAST IT. THE MACHINE ALARMED AND BLOOD WAS VISUALLY OBSERVED LEAKING OUT OF THE TUBING AND ONTO THE FLOOR. NO BLOODLINE OR CLAMP DAMAGE WAS VISIBLE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 20CC. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. A KELLY CLAMP WAS PUT ON THE MEDICATION LINE AND THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE SAME MACHINE. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISCARDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818137 CUSTOM COMBI SET SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK ERIKA DE REYNOSA, S.A. DE C.V. 16JR01244

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR FRESENIUS 2008K HEMODIALYSIS MACHINE