BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 11531928 · Received March 19, 2021

    Report

    Report Number
    1713747-2021-00081
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    March 3, 2021
    Report Date
    April 3, 2021
    Manufacturer
    OGDEN MANUFACTURING PLANT
    Product Code
    KDI
    UDI-DI
    00840861100156
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 ONE NON-CONFORMANCE IN THE PRODUCTION OF THIS LOT WHICH WAS 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.

    Description of Event or Problem · 0

    THE DIRECTOR OF DIALYSIS (DOD) FROM A HEMODIALYSIS (HD) USER FACILITY REPORTED THAT AN EXTERNAL DIALYZER BLOOD LEAK OCCURRED WITHIN THE FIRST TEN MINUTES OF A PATIENT¿S HD TREATMENT. BLOOD WAS VISUALLY OBSERVED DRIPPING FROM THE DIALYZER ONTO THE FLOOR. THE TREATMENT WAS SUSPENDED, AND THE MAJORITY OF THE PATIENT¿S BLOOD WAS RETURNED. THE DOD STATED THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS LESS THAN 50 ML. THERE WERE NO MACHINE ALARMS LEADING UP TO THE LEAK, AND THERE WAS NO DAMAGE IDENTIFIED ON THE DIALYZER PRIOR TO SET UP. FURTHERMORE, NO LEAKS WERE NOTED DURING PRIMING. AFTER THE EVENT, ADDITIONAL EXAMINATION OF THE DIALYZER REVEALED THERE WAS A CRACK ALONG THE BODY OF THE DEVICE, LONGITUDINALLY, MEASURING APPROXIMATELY ONE QUARTER OF AN INCH IN LENGTH. THE DOD STATED THE DIALYZER WAS NOT DROPPED PRIOR TO USE. THE PATIENT WAS DIALYZING ON A FRESENIUS 2008T HD MACHINE WITH FRESENIUS BLOODLINES. A BLOOD CULTURE WAS ORDERED AND THE DOD CONFIRMED THE RESULTS WERE FOUND TO BE NEGATIVE. THE DOD 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 DIALYZER WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED. IN ADDITION, NO COMPANION SAMPLES WERE AVAILABLE TO BE RETURNED AND THERE WERE NO PICTURES TAKEN OF THE DAMAGED DIALYZER. THE DOD STATED THERE WERE NO FURTHER ISSUES ENCOUNTERED DURING USE OF DIALYZERS FROM THIS LOT.

    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

    THE DIRECTOR OF DIALYSIS (DOD) FROM A HEMODIALYSIS (HD) USER FACILITY REPORTED THAT AN EXTERNAL DIALYZER BLOOD LEAK OCCURRED WITHIN THE FIRST TEN MINUTES OF A PATIENT¿S HD TREATMENT. BLOOD WAS VISUALLY OBSERVED DRIPPING FROM THE DIALYZER ONTO THE FLOOR. THE TREATMENT WAS SUSPENDED, AND THE MAJORITY OF THE PATIENT¿S BLOOD WAS RETURNED. THE DOD STATED THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS LESS THAN 50 ML. THERE WERE NO MACHINE ALARMS LEADING UP TO THE LEAK, AND THERE WAS NO DAMAGE IDENTIFIED ON THE DIALYZER PRIOR TO SET UP. FURTHERMORE, NO LEAKS WERE NOTED DURING PRIMING. AFTER THE EVENT, ADDITIONAL EXAMINATION OF THE DIALYZER REVEALED THERE WAS A CRACK ALONG THE BODY OF THE DEVICE, LONGITUDINALLY, MEASURING APPROXIMATELY ONE QUARTER OF AN INCH IN LENGTH. THE DOD STATED THE DIALYZER WAS NOT DROPPED PRIOR TO USE. THE PATIENT WAS DIALYZING ON A FRESENIUS 2008T HD MACHINE WITH FRESENIUS BLOODLINES. A BLOOD CULTURE WAS ORDERED AND THE DOD CONFIRMED THE RESULTS WERE FOUND TO BE NEGATIVE. THE DOD 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 DIALYZER WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED. IN ADDITION, NO COMPANION SAMPLES WERE AVAILABLE TO BE RETURNED AND THERE WERE NO PICTURES TAKEN OF THE DAMAGED DIALYZER. THE DOD STATED THERE WERE NO FURTHER ISSUES ENCOUNTERED DURING USE OF DIALYZERS FROM THIS LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426002 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OGDEN MANUFACTURING PLANT 0500318E 20SU02006 00840861100156

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR FRESENIUS 2008T MACHINE.| FRESENIUS 2008T MACHINE.| FRESENIUS BLOODLINES.| FRESENIUS BLOODLINES.