BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURORA PLASMAPHERESIS SYSTEM

    MDR report key: 17794820 · Received September 21, 2023

    Report

    Report Number
    3004548776-2023-00315
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    August 24, 2023
    Report Date
    September 25, 2024
    Manufacturer
    FENWAL INTERNATIONAL INC.
    Product Code
    GKT
    PMA / PMN Number
    BK110072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FRESENIUS KABI RECEIVED A REPORT FROM THE (B)(6) CENTER STATING A DONOR RETURNED TO THE CENTER FOLLOWING DONATION AND REPORTED TWO DISCOLORED URINES AT HOME. THE DONOR DENIED ANY OTHER SIGNS OR SYMPTOMS. THE MSS ENCOURAGED THE DONOR TO INCREASE FLUIDS AND SEEK MEDICAL ATTENTION FROM THEIR PRIMARY CARE PHYSICIAN. IT WAS REPORTED THAT THE DONOR DID GO TO THE EMERGENCY ROOM, BUT NO ADDITIONAL INFORMATION ON ANY MEDICAL INTERVENTION HAS BECOME AVAILABLE. ALTHOUGH DISCOLORED URINE IS A KNOWN POSSIBLE SIDE EFFECT OF PLASMA DONATION, FRESENIUS KABI IS REPORTING THIS EVENT CONSERVATIVELY AS IT IS NOT KNOWN WHAT TREATMENT THE DONOR WAS GIVEN AT THE EMERGENCY ROOM. THE BATCH RECORD FOR THE AURORA DISPOSABLE KIT MATERIAL 4R2256, BATCH FA23G11260 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE. THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING.

    Description of Event or Problem · 0

    NO SAMPLE OR PICTURE WAS AVAILABLE FOR ANALYSIS. THE FOLLOWING PROBABLE ROOT CAUSES HAVE BEEN IDENTIFIED: 1) ROUGH SURFACE FINISH OF THE ROLLER PINS, 2) KINK, SQUEEZE OR TWISTED TUBING CREATED BY THE PUMP, 3) STOPPED ROLLER INSIDE THE PUMP THE FOLLOWING CORRECTIVE ACTIONS WERE DEFINED: 1) IMPROVED DETECTION OF ROLLER CAGES AT RISK OF HAVING A STUCK ROLLER, 2) IMPROVEMENT OF CURRENT ROLLER PIN SURFACE FINISH, 3) INSTRUCT OPERATORS AND SERVICE TECHNICIANS NOT TO USE LUBRICANTS ON THE ROLLER CAGES. ALTHOUGH DISCOLORED URINE IS A KNOWN POSSIBLE SIDE EFFECT OF PLASMA DONATION, FRESENIUS KABI REPORTED THIS EVENT CONSERVATIVELY AS IT IS NOT KNOWN WHAT TREATMENT THE DONOR WAS GIVEN AT THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060695 AURORA PLASMAPHERESIS SYSTEM AURORA PLASMAPHERESIS SYSTEM GKT FENWAL INTERNATIONAL INC. N/A FA23G11260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization