BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMICUS SEPARATOR SYSTEM

    MDR report key: 12410810 · Received September 1, 2021

    Report

    Report Number
    3004548776-2021-00114
    Event Type
    Death
    Date Received
    September 1, 2021
    Date of Event
    July 26, 2021
    Report Date
    August 2, 2021
    Manufacturer
    FENWAL INTERNATIONAL INC.
    Product Code
    GKT
    PMA / PMN Number
    BK960005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INITIAL MDR INFORMATION: (B)(6) CLINIC REPORTED THAT A PATIENT PASSED AWAY AFTER GETTING A PLATELET TRANSFUSION. THE PRODUCT WAS COLLECTED ON (B)(6) 2021 AND THE TRANSFUSION OCCURRED ON (B)(6) 2021. THE PATIENT HAD A SEPTIC TRANSFUSION REACTION, EMERGENCY CPR WAS UNSUCCESSFUL, AND THE PATIENT EXPIRED ON (B)(6) 2021. PER THE AMERICAN RED CROSS, THE PRODUCT WAS COLLECTED ON AMICUS AS A DOUBLE PLATELET PRODUCT COLLECTION WITH INTERSOL. THE FINAL STORAGE CONTAINER WAS FROM A CERUS KIT. THE CO-PRODUCT PLATELET PRODUCT WAS ALSO TRANSFUSED AT (B)(6) CLINIC AND THE PATIENT DID NOT HAVE ANY REACTION. THE PATIENT WAS LATER CULTURED AND NEGATIVE FOR BACTERIA. THE TWO PLASMA PRODUCTS WERE BOTH QUARANTINED. ONE WAS QUARANTINED ON (B)(6) 2021 AT SOUTHEASTERN OHIO REGIONAL MEDICAL CENTER. ONE WAS LOCATED IN-HOUSE (ARC) AND QUARANTINED. AS OF (B)(6) 2021, BOTH PLASMA PRODUCTS REMAIN QUARANTINED AND ARE IN-HOUSE AT THE COLUMBUS MANUFACTURING LOCATION. (B)(6) CLINIC PERFORMED A PRELIMINARY CULTURE ON THE PLATELET PRODUCT AND FOUND THE FOLLOWING BACTERIA: BACILLUS SPECIES, ACINETOBACTER BAUMANNII COMPLEX, LECLERCIA ADECARBOXYLATA AND STAPHYLOCOCCUS SAPROPHYTICUS. NO CULTURE WAS PERFORMED ON THE PATIENT'S BLOOD POST TRANSFUSION; HOWEVER, A CULTURE WAS PERFORMED ON A POST-TRANSFUSION TYPE AND SCREEN SAMPLE WHICH WAS POSITIVE ON 5 BOTTLES FOR ACINETOBACTER BAUMANNII AND LECLERCIA ADECARBOXYLATA. PLEASE SEE ATTACHED DOCUMENT FOR DETAILS OF REPORTED INCIDENT AND INVESTIGATION. FOLLOW-UP MDR INFORMATION: UPDATE AS OF 08 FEB 2022: FRESENIUS KABI INVESTIGATION. VISUAL INSPECTION OF THE RETAINED SAMPLE FOR THE INTERSOL SOLUTION PRODUCT CODE 6B7880, BATCH FM21E04048 WAS PERFORMED. THE UNIT WAS VISUALLY INSPECTED PER THE APPLICABLE SPECIFICATION WITH SATISFACTORY RESULTS. THE INTERSOL SOLUTION WAS CLEAR AND NO OBVIOUS DEFECTS WERE FOUND THAT COULD CONTRIBUTE TO THE REPORTED BACTERIAL CONTAMINATION. THE USED AMICUS KIT, BATCH FA21E24129 , WAS NOT RECEIVED FROM THE CUSTOMER FOR EVALUATION. HOWEVER, FRESENIUS KABI DID COMPLETE AN INTERNAL INVESTIGATION (RECORD # 1163181). MICROBIOLOGICAL TESTING RESULTS WERE REVIEWED WITH SATISFACTORY RESULTS FOR THE AMICUS KIT BATCH FA21E24129 MANUFACTURING PERIOD, INCLUDING THE PREVIOUS MONTH. THE BACTERIA IDENTIFIED BY THE CUSTOMER WAS NOT FOUND IN THE HAINA PLANT MICRO-FLORA DURING THE MANUFACTURING PERIOD OF THE REPORTED BATCH. CURRENT CONTROLS IN PLACE AT THE HAINA MANUFACTURING FACILITY INCLUDE: MICROBIOLOGY MONITORING, PRODUCT E-BEAM STERILIZATION, IN PROCESS SAMPLING QUALITY INSPECTION, AND POST STERILIZATION SAMPLING FINAL INSPECTION. BASED ON THE KNOWLEDGE OF HOW THE PRODUCT IS USED IN THE FIELD AND THE CO-PRODUCT TESTING NEGATIVE FOR BACTERIA, FRESENIUS-KABI'S INVESTIGATION HAS FOUND THAT THERE IS NO DIRECT CORRELATION BETWEEN THE PLANT FLORA AND THE BACTERIA FROM THIS INCIDENT.

    Description of Event or Problem · 1

    (B)(6) CLINIC REPORTED THAT A PATIENT PASSED AWAY AFTER GETTING A PLATELET TRANSFUSION. THE PRODUCT WAS COLLECTED ON (B)(6) 2021 AND THE TRANSFUSION OCCURRED ON (B)(6) 2021. THE PATIENT HAD A SEPTIC TRANSFUSION REACTION, EMERGENCY CPR WAS UNSUCCESSFUL, AND THE PATIENT EXPIRED ON (B)(6) 2021. PER THE (B)(6), THE PRODUCT WAS COLLECTED ON AMICUS AS A DOUBLE PLATELET PRODUCT COLLECTION WITH INTERSOL. THE FINAL STORAGE CONTAINER WAS FROM A CERUS KIT. THE CO-PRODUCT PLATELET PRODUCT WAS ALSO TRANSFUSED AT CLEVELAND CLINIC AND THE PATIENT DID NOT HAVE ANY REACTION. THE PATIENT WAS LATER CULTURED AND NEGATIVE FOR BACTERIA. THE TWO PLASMA PRODUCTS WERE BOTH QUARANTINED. ONE WAS QUARANTINED ON (B)(6) 2021 AT (B)(6) MEDICAL CENTER. ONE WAS LOCATED IN-HOUSE (ARC) AND QUARANTINED. AS OF (B)(6) 2021, BOTH PLASMA PRODUCTS REMAIN QUARANTINED AND ARE IN-HOUSE AT THE (B)(6) MANUFACTURING LOCATION. (B)(6) CLINIC PERFORMED A PRELIMINARY CULTURE ON THE PLATELET PRODUCT AND FOUND THE FOLLOWING BACTERIA: BACILLUS SPECIES, ACINETOBACTER BAUMANNII COMPLEX, LECLERCIA ADECARBOXYLATA AND STAPHYLOCOCCUS SAPROPHYTICUS. NO CULTURE WAS PERFORMED ON THE PATIENT'S BLOOD POST TRANSFUSION; HOWEVER, A CULTURE WAS PERFORMED ON A POST-TRANSFUSION TYPE AND SCREEN SAMPLE WHICH WAS POSITIVE ON 5 BOTTLES FOR ACINETOBACTER BAUMANNII AND LECLERCIA ADECARBOXYLATA. PLEASE SEE ATTACHED DOCUMENT FOR DETAILS OF REPORTED INCIDENT AND INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304667 AMICUS SEPARATOR SYSTEM AMICUS APHERESIS KIT GKT FENWAL INTERNATIONAL INC. N/A FA21E24129

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death