BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY

    MDR report key: 7776687 · Received August 13, 2018

    Report

    Report Number
    1713747-2018-00295
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 30, 2018
    Report Date
    September 17, 2018
    Manufacturer
    OGDEN MANUFACTURING PLANT
    Product Code
    KDI
    UDI-DI
    00840861100125
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    510K# CORRECTED TO K002761.

    Additional Manufacturer Narrative · 0

    CORRECTED BRAND NAME TO OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY CORRECTED CATAOG NUMBER TO 0500318E, UDI TO (B)(4).

    Additional Manufacturer Narrative · 1

    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 WERE TWO APPROVED TEMPORARY DEVIATION NOTICE (DN) REPORTED ON THE LOT WHICH WERE UNRELATED TO THE COMPLAINT EVENT. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 CLINICAL MANAGER REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED IMMEDIATELY AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. THE LEAK WAS VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 100ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618029 OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OGDEN MANUFACTURING PLANT 18DU07013 00840861100125

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR