BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 200NR DIALYZER FINISHED ASSEMBLY

    MDR report key: 4920990 · Received July 15, 2015

    Report

    Report Number
    1713747-2015-00329
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 17, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K002277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF THE INVESTIGATION A REVIEW WAS PERFORMED ON THE SUB-ASSEMBLY LOT NUMBERS USED IN THE PRODUCTION OF THE FINISHED LOT. THERE WERE NO NON-CONFORMANCES IN ANY OF THE RAW MATERIALS USED IN THE FINISHED LOTS PRODUCTION INCLUDING FIBER BUNDLE AND POLYCARBONATE MOLDED COMPONENTS RELATED TO THE REPORTED COMPLAINT EVENT. HOWEVER, A SUPPLIER NON-CONFORMANCE (NCR 214-2014) WAS OPENED TO ADDRESS O-RING BAGS THAT WERE MIXED WITH DIFFERENT SIZE O-RINGS. ALL DISCREPANT O-RINGS WERE INSPECTED AND DISCARDED. ALSO AS PART OF THE INVESTIGATION, THE REPORTED DIALYZER LOT SUB-ASSEMBLY COMPONENTS WERE COMPARED TO THE CORRESPONDING BILL OF MATERIALS. IT WAS CONFIRMED THAT THE CORRECT COMPONENTS WERE USED DURING THE MANUFACTURE OF DIALYZER LOT 14NU04020. IN ADDITION, REVIEW OF THE BATCH PRODUCTION RECORD INDICATES THAT PRODUCTION QUALITY SPECIALISTS FOR ALL SHIFTS VERIFIED THAT THE COMPONENTS USED DURING ASSEMBLY MATCHED THE BILL OF MATERIAL LIST. THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVALUATION. THEREFORE, THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. ALTHOUGH REQUESTED MEDICAL RECORDS WERE NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    THE POST MARKET CLINICAL DEPARTMENT IS IN THE PROCESS OF REQUESTING PT MEDICAL RECORDS AND TREATMENT DATA INFO REGARDING THE REPORTED EVENT OF SHORTNESS OF BREATH AND LOSS OF CONSCIOUSNESS AFTER 10 MINUTES OF HEMODIALYSIS. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AN ACUTE DIALYSIS NURSE REPORTED THAT A HOSPITALIZED PT EXPERIENCED AN ADVERSE EFFECT TEN MINUTES INTO THEIR HEMODIALYSIS TREATMENT. THE PT DEVELOPED SEVERE SHORTNESS OF BREATH AND THEIR PULSE WAS WEAK. DIALYSIS WAS STOPPED, BLOOD WAS NOT RETURNED. DIALYSIS RESTARTED WITH ANOTHER MFR'S DIALYZER AND PT HAD NO ISSUES. ACCORDING TO THE FOLLOW UP RECEIVED FROM THIS NURSE, RESCUE BREATHING WAS PROVIDED BUT CHEST COMPRESSIONS WERE NOT REQUIRED. THE PT REPORTEDLY STARTED BREATHING ON HIS OWN AND RESCUE BREATHING WAS STOPPED. ONCE THE PT WAS STABILIZED, HE WAS ABLE TO COMPLETE TREATMENT USING AN OTHER MFR'S DIALYZER WITHOUT FURTHER SYMPTOMS. ESTIMATED BLOOD LOSS 250ML. THE DIALYZER WAS DISCARDED; THEREFORE IT IS NOT AVAILABLE FOR RETURN. FOLLOW UP ALSO REVEALED THIS PT HAD A SIMILAR EVENT AT HIS OUTPATIENT DIALYSIS FACILITY ON (B)(6) 2015 WHICH IS THE REASON FOR THIS HOSPITAL ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460599 OPTIFLUX 200NR DIALYZER FINISHED ASSEMBLY KDI FRESENIUS MEDICAL CARE NORTH AMERICA 14NU04020

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R