BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 18943265 · Received March 20, 2024

    Report

    Report Number
    0001713747-2024-00210
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    January 29, 2024
    Report Date
    April 23, 2024
    Manufacturer
    OGDEN MANUFACTURING PLANT
    Product Code
    KDI
    UDI-DI
    00840861100156
    PMA / PMN Number
    K162488
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 WERE MULTIPLE APPROVED TEMPORARY DEVIATION NOTICES (DNS) 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. CONTINUOUS IMPROVEMENT IS OF THE UTMOST IMPORTANCE TO FRESENIUS MEDICAL CARE AS WE STRIVE TO PROVIDE DIALYSIS PRODUCTS OF THE HIGHEST QUALITY TO OUR PATIENTS. REPORTS OF LEAKING PRODUCT ARE INVESTIGATED BOTH INDIVIDUALLY AS COMPLAINTS, AS WELL AS VIA THE NC/CAPA PROGRAM, IN ORDER TO ASSESS AND IMPROVE OUR PRODUCTS AND PROCESSES. CAPAS FOR VISION SYSTEMS AND BLOOD LEAK REDUCTION ARE RECENT EXAMPLES OF LEAK RELATED INVESTIGATIONS DIRECTED AT AN OVERALL REDUCTION IN DIALYZER LEAKS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A USER FACILITY CLINICAL MANAGER (CM) REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED LESS THAN FIVE MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS INTERNAL, AND BLOOD WAS CONFIRMED TO BE VISUALLY OBSERVED IN THE DIALYSATE. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THE DIALYSATE WAS TESTED WITH A BLOOD TEST STRIP, AND IT TESTED POSITIVE FOR BLOOD. THERE WAS NO PHYSICAL DAMAGE NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE ALSO BEING USED. AFTER THE LEAK OCCURRED, THE TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS 250 ML. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION AS IT WAS REPORTEDLY DISCARDED.

    Description of Event or Problem · 0

    A USER FACILITY CLINICAL MANAGER (CM) REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED LESS THAN FIVE MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS INTERNAL, AND BLOOD WAS CONFIRMED TO BE VISUALLY OBSERVED IN THE DIALYSATE. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THE DIALYSATE WAS TESTED WITH A BLOOD TEST STRIP, AND IT TESTED POSITIVE FOR BLOOD. THERE WAS NO PHYSICAL DAMAGE NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE ALSO BEING USED. AFTER THE LEAK OCCURRED, THE TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS 250 ML. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION AS IT WAS REPORTEDLY DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047409 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OGDEN MANUFACTURING PLANT 23PU01008 00840861100156

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male FRESENIUS 2008T MACHINE| FRESENIUS 2008T MACHINE| FRESENIUS BLOODLINES| FRESENIUS BLOODLINES