BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMICUS SEPARATOR SYSTEM

    MDR report key: 8166393 · Received December 14, 2018

    Report

    Report Number
    3004548776-2018-00002
    Event Type
    Death
    Date Received
    December 14, 2018
    Date of Event
    May 16, 2018
    Report Date
    November 28, 2018
    Manufacturer
    FENWAL INTERNATIONAL INC.
    Product Code
    GKT
    UDI-DI
    04086000101325
    PMA / PMN Number
    BK960005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS SENT TO THE FDA ON MARCH 14, 2019 IN RESPONSE TO A LETTER RECEIVED ON JANUARY 28, 2019 ASKING FOR ADDITIONAL INFORMATION REGARDING THIS REPORTED INCIDENT. FRESENIUS KABI IS THE MANUFACTURER OF THE AMICUS SEPARATOR SYSTEM. THE (B)(6) USES THE MEDICAL DEVICE TO COLLECT PLATELETS FROM A DONOR AND THEN FURTHER MANUFACTURES THE PLATELET PRODUCT. THE COLLECTED PLATELET PRODUCT IS THEN DISTRIBUTED TO ARC'S CUSTOMERS SUCH AS HOSPITALS AND\OR OTHER FACILITIES FOR PATIENTS NEEDING PLATELET TRANSFUSIONS. THE INCIDENT REPORTED IN THIS MDR WAS REPORTED TO US BY ARC BUT PERTAINS TO A PATIENT WHOM EXPIRED AT THE HOSPITAL/FACILITY THAT RECEIVED THE PLATELETS FROM (B)(6) (NOT DIRECTLY FROM FRESENIUS KABI). FRESENIUS KABI DOES NOT HAVE THE INFUSED PATIENT'S INFORMATION. COMPLAINT (B)(4) WAS RECEIVED AGAINST MATERIAL CODE 4R2340, LOT NUMBER FA18A25104. THE CUSTOMER STATES THAT A FACILITY USING THEIR COLLECTED PLATELET PRODUCT REPORTED A PATIENT EXPIRED POST PLATELET TRANSFUSION (ASSUMED TO BE DUE TO BACTERIAL CONTAMINATION). NEITHER A SAMPLE NOR PICTURE WERE AVAILABLE FOR FURTHER EVALUATION. COMPLAINT (B)(4) INVESTIGATION RESULTS: REVIEWED LOT MANUFACTURING RECORDS FOR ANY DOCUMENTED EXCEPTIONS ON THE FINISHED GOOD LOT AND ASSOCIATED SOLUTION BATCHES. NO EXCEPTIONS WERE FOUND. REVIEWED MANUFACTURING RECORDS FOR RESULTS OF IN-PROCESS AND FINAL RELEASE QUALITY TESTS. RESULTS WERE SATISFACTORY. THE BACTERIA REPORTED WAS NOT IDENTIFIED IN THE (B)(6), DOMINICAN REPUBLIC MICROBIAL FLORA. PERFORMED A REVIEW ON COMPLAINTS RECEIVED FOR AFFECTED LOT AND OTHER AMICUS KIT BATCHES THAT USED THE SAME SOLUTION BATCHES. NO COMPLAINTS HAVE BEEN REPORTED FOR ADVERSE REACTIONS OR BACTERIAL CONTAMINATION ON ANY OF THE LOTS REVIEWED. A REVIEW OF CAPAS WAS CONDUCTED AND THERE ARE NO CAPAS RELATED TO THE DEFICIENCY LISTED IN THIS COMPLAINT. CONCLUSION: THE ABOVE INVESTIGATION FOR THIS LOT DOES NOT REVEAL ANY PROCESS, PRODUCT OR MANUFACTURING NONCONFORMITY THAT WOULD CONTRIBUTE TO BACTERIAL CONTAMINATION. THE LOT MEETS ALL THE RELEASE REQUIREMENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A FACILITY USING THEIR COLLECTED PLATELET PRODUCT REPORTED A PATIENT EXPIRED POST PLATELET TRANSFUSION. POST PLATELET TRANSFUSION, THE PLATELET PRODUCT TESTED POSITIVE FOR ACINETOBACTER BAUMANNII COMPLEX. THE PLATELET PRODUCT WAS COLLECTED ON (B)(6) 2018. THE COLLECTED PLATELETS WERE TREATED WITH PAS. THE PATIENT WAS TRANSFUSED WITH THE PLATELET PRODUCT ON (B)(6) 2018. DURING AN AMICUS DONATION, TWO PLATELET PRODUCTS MAY BE COLLECTED. THE DONATION RELATED TO THE PLATELET TRANSFUSION DID INVOLVE TWO COLLECTED PLATELET PRODUCTS. THE CO-PRODUCT WAS TRACKED AND SUBSEQUENTLY TESTED FOR BACTERIA. THE TEST RESULTS WERE NEGATIVE FOR BACTERIA. IF THE AMICUS KIT AND/OR SOLUTIONS WERE THE SOURCE OF THE BACTERIA, IT COULD BE EXPECTED THAT BOTH COLLECTED PLATELET PRODUCTS FROM THE SINGLE DONATION WOULD CONTAIN THE BACTERIA. THE AGITATOR MACHINE TESTED POSITIVE FOR THE BACTERIA. THE FOLLOWING INFORMATION HAS BEEN REPORTED TO US BY THE (B)(6) REGARDING THE CDC INVESTIGATION: A. BAUMANNII WAS ISOLATED AND THE FOLLOWING CDC INVESTIGATION RESULTS ARE CONSIDERED RELEVANT TO THE INVESTIGATION. WHOLE GENOME SEQUENCED BY CDC; 2 ISOLATES, 100% IDENTICAL TO EACH OTHER; WHEN COMPARING BETWEEN CASES, THERE ARE 24-25 SNPS BETWEEN THE ISOLATES; DIFFERENCE: (B)(4). A BATCH TRACEABILITY WAS PERFORMED FOR THE SOLUTIONS USED IN AMICUS KIT PRODUCT CODE 4R2340, BATCH FA18A25104. THERE ARE NO COMMON PRE-ATTACHED SOLUTION SUBASSEMBLY LOT NUMBERS BETWEEN THE TWO AMICUS KIT LOTS INVOLVED IN THREE RECENTLY REPORTED CASES IN 2018. THERE ARE NO RELATED COMPLAINTS AGAINST OTHER AMICUS KIT BATCHES THAT USED THE SAME SOLUTION BATCHES. BOTH PRODUCTION PLANTS INVOLVED IN THE MANUFACTURE OF AMICUS KITS WERE TESTED FOR THE PRESENT BACTERIA. NEITHER PLANT TESTED POSITIVE FOR ACINETOBACTER BAUMANNII COMPLEX. INVESTIGATION RESULTS THUS FAR: THERE IS NO EVIDENCE IMPLICATING OUR PRODUCTS AS A ROOT CAUSE FOR THE ACINETOBACTER CONTAMINATION INCIDENCES AS SHOWN IN THE FOLLOWING ANALYSES. A CAPA INVESTIGATION HAS BEEN OPENED AND THE NEXT STEPS WERE DISCUSSED WITH THE FDA: 3RD PARTY MICROBIOLOGIC TESTS AT BOTH PRODUCTION UNITS HAVE BEEN INITIATED. TESTING ON THE ARC ISOLATES OF ACINETOBACTER HAVE BEEN INITIATED TO EVALUATE RESISTANCE TO MOIST HEAT AND RADIATION. REVIEWING MANUFACTURING CAPA, ISSUES AND NONCONFORMITIES TO DETERMINE IF ANY HAVE THE ABILITY TO IMPACT INTEGRITY AND/OR STERILITY OF THE KITS. INVESTIGATIONS FROM FDA/CDC HAVE BEEN REQUESTED TO CONFIRM DATA ALONG WITH A REQUEST FOR DNA SEQUENCE DATA, NOT AVAILABLE TO THE PUBLIC AT THIS TIME. WITH THE INVESTIGATION IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005848 AMICUS SEPARATOR SYSTEM AMICUS APHERESIS KIT GKT FENWAL INTERNATIONAL INC. N/A FA18A25104 04086000101325

    Patients

    Seq Age Sex Outcome Treatment
    1 Death