BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 6717764 · Received July 17, 2017

    Report

    Report Number
    1713747-2017-00238
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Date of Event
    June 20, 2017
    Report Date
    July 17, 2017
    Manufacturer
    OGDEN MANUFACTURING PLANT
    Product Code
    KDI
    UDI-DI
    00840861100156
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: THE REPORTED COMPLAINT WAS NOT CONFIRMED AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR MANUFACTURER EVALUATION. AS SUCH, A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE. A PRODUCTION RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WAS NO INDICATION OF PRODUCT NON-ACCEPTANCE OR DEVIATION IN THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE REVIEW INCLUDED A CHECK OF NON-CONFORMANCES, REWORK, LABELING, PROCESS CONTROLS, AND ANY OTHER OCCURRENCE IN PRODUCTION POTENTIALLY RELATED TO THE COMPLAINT. THE LOT PASSED ALL RELEASE CRITERIA. A 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 NURSE REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED SHORTLY AFTER THE INITIATION OF A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE MACHINE ALARMED AS APPROPRIATE. BLOOD TEST STRIPS WERE USED AND DID NOT CONFIRM THE PRESENCE OF BLOOD; HOWEVER, BLOOD WAS VISUALLY OBSERVED IN THE DIALYZER HOUSING COMPARTMENT. NO DIALYZER DAMAGE WAS VISIBLE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 10ML AS THE PATIENT'S BLOOD WAS RETURNED AND THE BLOOD LOSS WAS LIMITED TO THAT WITHIN THE DIALYZER. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT COMPLETED TREATMENT WITH A NEW SET-UP ON THE SAME MACHINE. THE COMPLAINT DEVICE WAS STATED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497957 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OGDEN MANUFACTURING PLANT 17CU03007 00840861100156

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR FRESENIUS 2008T HEMODIALYSIS MACHINE| FRESENIUS BLOODLINES