BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURORA PLASMAPHERESIS SYSTEM

    MDR report key: 17837409 · Received September 28, 2023

    Report

    Report Number
    3004548776-2023-00336
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    September 7, 2023
    Report Date
    February 1, 2024
    Manufacturer
    FENWAL INTERNATIONAL INC.
    Product Code
    GKT
    PMA / PMN Number
    BK110072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FRESENIUS KABI GERMANY REPORTED AN INCIDENCE OF HEMOLYTIC PLASMA DURING A DONATION ON THE AURORA PLASMAPHERESIS SYSTEM. THE DONOR EXPERIENCED DISCOLORED URINE AND WAS SENT TO THE HOSPITAL. SAMPLES HAVE BEEN RETURNED FOR EVALUATION AND THE DEVICE LOG FILES ARE BEING REVIEWED. A FOLLOW-UP MDR WILL BE FILED ONCE THE INVESTIGATION OF THIS EVENT IS COMPLETE.

    Description of Event or Problem · 0

    SAMPLE EVALUATION FINDINGS: -ONE CUSTOMER PHOTO SHOWS THE PLASMALINK POOLING BOTTLE CONTAINING PLASMA WITH A RED DISCOLORATION; -ONE CUSTOMER PHOTO SHOWS A BLOOD CONTAMINATED KIT INSTALLED ON THE INSTRUMENT; THE PLASMA LINE CONTAINS PLASMA WITH A RED DISCOLORATION; -TWO CUSTOMER PHOTOS SHOW FILLED TEST TUBES CONTAINING LIQUID WITH A RED DISCOLORATION; -THE BLOOD PUMP TUBING BETWEEN Y2 CONNECTOR AND Y3 CONNECTOR WAS MEASURED APPROXIMATELY 7-6/8", AS PER THE DRAWING, THIS IS WITHIN THE TOLERANCE OF 7-5/8" +/- 1/8"; -THE BLOOD PUMP TUBING (THE TUBING BETWEEN Y2 AND Y3) INSTALLS PROPERLY IN THE PUMP AND IS VISUALLY NOT TOO LONG; -THE CONTENTS OF THE KIT WERE DRAINED OUT FOR FURTHER BLOOD ANALYSIS; -NO SCRAPE MARKS WERE FOUND ON THE ROTOR AND INSIDE THE CASE; -NO LEAKS WERE FOUND IN THE ROTOR MEMBRANE; -THERE WAS A NONCONCENTRIC IMPRESSION WEAR ON THE SEAL RING FROM THE EYELET, INDICATING A MISALIGNMENT OF THE ROTOR TO THE CASE/PIVOT; -THE PIVOT SHOWED MODERATE AND UNEVEN WEAR; -APPROXIMATELY HALF OF THE RIM OF THE EYELET FLANGE FORMED A WIDE RIDGE; -THE DENTAL CAST OF ROTOR BEARING CAVITY SHOWED NO DEFORMATION OR DEFECTS; -THE OVALITY TEST WAS PASSED; -THE I.D. OF THE CASE PLASMA PORT WAS CONCENTRIC TO THE O.D. CUSTOMER'S COMPLAINT IS CONFIRMED. THE BATCH RECORD FOR PRODUCT CODE 6R2262, LOT FA23F05306 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE OF THIS DEFECT. THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING. CURRENT CONTROLS: TO ASSURE INTEGRITY OF THE KIT, THE FOLLOWING CONTROLS ARE ESTABLISHED AT THE DISPOSABLE MANUFACTURING SITE: -IN PROCESS SAMPLING QUALITY INSPECTION; -POST STERILIZATION SAMPLING FINAL INSPECTION; -QUALITY AND MANUFACTURING INSPECTION. TRACK AND TREND: FRESENIUS KABI RECEIVED A TOTAL OF 2 DISCOLORED URINE INCIDENTS AGAINST PRODUCT CODE 6R2262, LOT FA23F05306. A MONTHLY TREND IS PERFORMED TO DETERMINE THE NEED TO INITIATE AN INVESTIGATION DUE TO AN INCREASE IN COMPLAINTS OR TO DETERMINE IF CORRECTIVE ACTIONS ARE NEEDED. AN ADVERSE TREND WAS OBSERVED FOR THIS DEFECT CATEGORY. CAPA 1700421 WAS ISSUED TO PERFORM THE APPLICABLE INVESTIGATION AND IDENTIFY CORRECTIVE ACTIONS. ROOT CAUSE IDENTIFIED IN CAPA 1700421: THE PRIMARY ROOT CAUSE IS THE SURFACE FINISH OF THE PIN, WHICH CAN CREATE FRICTION THAT STOPS THE ROLLER. THE STOPPED ROLLER PULLS TUBING, CREATING A KINK. IF THE ROLLER STOPPAGE OCCURS ON THE BLOOD PUMP AND THE KINK OCCURS ON RETURN, HEMOLYSIS IS NOT IMMEDIATELY DETECTED, LEADING TO DISCOLORED URINE. CONFOUNDING FACTORS INCLUDE APPLICATION OF SILICONE LUBRICANT, WHICH INCREASES THE LIKELIHOOD OF ROLLER STOPPAGE AND LONG/STRETCHED/TWISTED TUBING, WHICH INCREASES THE LIKELIHOOD OF A KINK. CORRECTIVE ACTION: THE FOLLOWING CORRECTIVE ACTIONS WERE DEFINED IN CAPA 1700421: -IMPROVED DETECTION OF ROLLER CAGES AT RISK OF HAVING A STUCK ROLLER; -IMPROVEMENT OF CURRENT ROLLER PIN SURFACE FINISH; -TO INSTRUCT OPERATORS AND SERVICE TECHNICIANS NOT TO USE LUBRICANTS ON THE ROLLER CAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231107 AURORA PLASMAPHERESIS SYSTEM AURORA PLASMAPHERESIS SYSTEM GKT FENWAL INTERNATIONAL INC. N/A FA23F05306

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization