BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM COMBI SET

    MDR report key: 8621092 · Received May 17, 2019

    Report

    Report Number
    8030665-2019-00742
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    May 6, 2019
    Report Date
    May 24, 2019
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FJK
    UDI-DI
    00840861100293
    PMA / PMN Number
    K962081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE REPORTED COMPLAINT WAS NOT CONFIRMED AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR MANUFACTURER EVALUATION. A PRODUCTION RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED BY THE MANUFACTURER. THERE WAS NO INDICATION OF PRODUCT NONACCEPTANCE, DEVIATION, NON-CONFORMANCE, REWORK, LABELING OR PROCESS CONTROL FAILURE DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE LOT MET ALL RELEASE CRITERIA. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT PHYSICAL EXAMINATION OF THE ACTUAL DEVICE. THEREFORE, THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 1

    A USER FACILITY NURSE REPORTED A BLOOD LEAK THAT OCCURRED AT THE BEGINNING OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED FROM A HOLE IN THE BOTTOM OF THE VENOUS CHAMBER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 50 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT SUCCESSFULLY COMPLETED TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT PROVIDED. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413526 CUSTOM COMBI SET SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK ERIKA DE REYNOSA, S.A. DE C.V. 18SR01242 00840861100293

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS 2008T MACHINE| FRESENIUS DIALYZER| FRESENIUS 2008T MACHINE| FRESENIUS DIALYZER