BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURORA PLASMAPHERESIS SYSTEM

    MDR report key: 19624558 · Received June 27, 2024

    Report

    Report Number
    3004548776-2024-00236
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    March 15, 2024
    Report Date
    October 14, 2024
    Manufacturer
    FENWAL INTERNATIONAL INC.
    Product Code
    GKT
    PMA / PMN Number
    BK110072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS EVENT. THE DONOR EXPERIENCED PAIN DURING THE DONATION WHICH LED TO ITS PREMATURE INTERRUPTION (DONATION STOPPED AT 322ML) DUE TO A SUPPOSED DIAGNOSIS OF HAEMATOMA. THE PAIN WORSENED ON THE EVENING OF THE DONATION, LEADING THE PATIENT TO GO TO EMERGENCY THE DAY AFTER THE BLOOD DONATION. THE TISSUE DIAGNOSIS WAS MADE IN THE EMERGENCY DEPARTMENT THE DAY AFTER THE BLOOD DONATION. WITH ANALGESIC AND ANTIBIOTIC TREATMENT, THE SYMPTOMS RAPIDLY RESOLVED. THE BLOOD DONOR WAS CONTACTED AGAIN 1 MONTH AFTER THE BLOOD DONATION AND IS DOING WELL, SYMPTOMS HAVE DISAPPEARED. THE BLOOD CENTER STAFF COLLECTED SAMPLES AND SUBJECTED THEM TO THE SEROLOGICAL TESTS FOR THE BIOLOGICAL QUALIFICATION OF DONATIONS. ALL SAMPLES WERE COMPLIANT. NO DEVICE WAS RETURNED TO FRESENIUS KABI FOR EVALUATION.

    Description of Event or Problem · 0

    THE FRANCE MARKET UNIT RECEIVED A REPORT DIRECTLY FROM THE ANSM (REPORT NUMBER (B)(4)) WHICH SEEMS TO HAVE BEEN DECLARED BY A PATIENT. DURING A PLASMA DONATION A DONOR EXPERIENCED SEVERE PAIN IN THEIR ARM. THE SUPERVISING DOCTOR STOPPED THE DONATION AND TOLD THE DONOR TO SEE THEIR DOCTOR. THE DONOR SUBSEQUENTLY EXPERIENCED A FEVER (39° C), NAUSEA, ARM NUMBNESS, AND A HAEMATOMA. THE DONOR WAS SEEN IN THE ER, WAS GIVEN THE DIAGNOSIS OF TISSUE INFECTION, AND WAS TREATED WITH ANTIBIOTICS. FOLLOW-UP WAS MADE TO THE MARKET UNIT ON (B)(6) 2024 TO OBTAIN MORE INFORMATION ABOUT THE DONATION. ALSO ASKED THE MARKET UNIT TO PROVIDE THE STATUS OF THE DONOR AFTER THEIR HOSPITAL VISIT AND TO CONFIRM THAT THE DONOR'S SYMPTOMS IMPROVED. AS OF JUNE 27, 2024, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE MARKET UNIT. THIS ADVERSE EVENT IS MOST LIKELY DUE TO PHLEBOTOMY SITE INFILTRATION/BLEEDING WITH ACCOMPANYING PHLEBITIS AND/OR INFECTION. ASSUMING THE THAT THE TREATING PHYSICIAN WAS CORRECT WITH HIS/HER DIAGNOSIS AND ANTIBIOTICS WERE INDEED REQUIRED TO TREAT THE PATIENT'S CONDITION TO PREVENT FURTHER INJURY, THE ADVERSE EVENT WOULD APPEAR TO BE SERIOUS. DUE TO NO FURTHER INFORMATION ABOUT THE DONOR FROM EITHER THE CENTER OR MARKET UNIT POST DONATION, THE CONCLUSION OF CAUSALITY REMAINS INCONCLUSIVE. THE BATCH RECORD 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. A GLOBAL COMPLAINT DATA REVIEW WAS PERFORMED TO ASSESS REPORTS ASSOCIATED WITH LOT FA23K07311. NO ADDITIONAL COMPLAINTS WERE REPORTED FOR BATCH FA23K07311 WITH THE CONDITION OF HEMATOMA AS OF JUNE 27, 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697679 AURORA PLASMAPHERESIS SYSTEM AURORA PLASMAPHERESIS SYSTEM GKT FENWAL INTERNATIONAL INC. N/A FA23K07311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other