BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMICUS DOUBLE NEEDLE ADVANCED KIT WITH PLATELET ADDITIVE SOLUTION CONNECTOR

    MDR report key: 21096343 · Received January 7, 2025

    Report

    Report Number
    3004548776-2025-00002
    Event Type
    Injury
    Date Received
    January 7, 2025
    Date of Event
    November 29, 2024
    Report Date
    May 27, 2025
    Manufacturer
    FENWAL INTERNATIONAL INC.
    Product Code
    GKT
    UDI-DI
    00810020440713
    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

    FRESENIUS KABI RECEIVED AN EMAIL FROM THE AMERICAN RED CROSS (ARC) ON DECEMBER 10, 2024 REGARDING A TRANSFUSION REACTION INVOLVING A PATHOGEN REDUCED PLATELET PRODUCT COLLECTED ON AMICUS LOT # FA24G19148, CODE 4R2352 USING FRESENIUS KABI INTERSOL PAS, LOT # FM24H16043. PER ARC, ON DECEMBER 05, 2024 A HOSPITAL REPORTED A POSSIBLE SEPTIC REACTION AFTER THE PRODUCT CULTURE TESTED SAMPLE FROM THE BLOOD BAG GREW GRAM NEGATIVE RODS. FURTHER INVESTIGATION REVEALED THAT THE SAMPLES TESTED POSITIVE FOR PAENIBACILLUS SP. BACKGROUND: COMPLAINT INFORMATION ((B)(4)): ARC#: (B)(4). LOCATION: (B)(6) HOSPITAL. PLATELET COLLECTION DATE: (B)(6) 2024. PLATELET TRANSFUSION DATE: (B)(6) 2024. PAS TREATED: YES. INTERCEPT TREATED: YES. BACTERIA DETECTED: PAENIBACILLUS SP. AMICUS PRODUCT INFORMATION: PRODUCT DESCRIPTION: AMICUS DOUBLE NEEDLE ADVANCED KIT. AMICUS CODE: 4R2352. AMICUS LOT: FA24G19148. FINAL MANUFACTURING: HAINA, DR. ACDA SOLUTION LOT: FM24F20049. NACI SOLUTION LOT: FM24F19041 AND FM24F21047. SOLUTION MANUFACTURING: MARICAO, PR. INTERSOL (PAS) PRODUCT INFORMATION: PRODUCT DESCRIPTION: INTERSOL SOLUTION PLATELET ADDITIVE SOLUTION 3. LNTERSOL CODE: 6B7880. INTERSOL LOT: FM24H16043. FINAL ASSEMBLY: MARICAO, PR. CERUS CORPORATIONS INTERCEPT PLATELET STORAGE CONTAINER PRODUCT INFORMATION: PRODUCT DESCRIPTION: INTERCEPT BLOOD SYSTEM FOR PLATELETS. LNTERCEPT CODE/MODEL: INT2230B. LNTERCEPT LOT: CE24E09A01. REGISTERED MANUFACTURER: CERUS CORPORATION, 1220 CONCORD, AVE, CONCORD CA, 94520, USA. NO ADDITIONAL POSSIBLE SEPTIC REACTION COMPLAINTS HAVE BEEN REPORTED FOR THE FINISHED AMICUS KIT LOT FA24G19148. NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR INTERSOL LOT FM24H16043. SAMPLES ARE CURRENTLY NOT AVAILABLE FOR EVALUATION. THE PLATELET DONATION WAS A TRIPLE DONATION. THERE WERE NO DEVIATIONS NOTED IN THE COLLECTION OR BLOOD COMPONENTS MANUFACTURING OF THE INVOLVED UNIT. CO-COMPONENTS WERE TRANSFUSED WITHOUT INCIDENT. THE PATIENT WHO HAD THE REACTION RECEIVED BOTH CONTAINER 2 AND CONTAINER 3. CONTAINER 2 WAS TRANSFUSED ON (B)(6) 2024. THE PATIENT EXPERIENCED CHILLS FOLLOWING TRANSFUSION. GRAM STAIN WAS NEGATIVE. CONTAINER 3 WAS TRANSFUSED ON (B)(6) 2024. THE PATIENT DID NOT HAVE A REACTION AND CONTAINER 3 WAS NOT TESTED/CULTURED. INITIAL PATIENT CULTURE FROM BLOOD COLLECTED (B)(6) 2024 WAS NEGATIVE. SUBSEQUENT PATIENT BLOOD CULTURES HAVE BEEN COLLECTED WITH RESULTS PENDING. CONTAINER 1 WAS TRANSFUSED TO A DIFFERENT PATIENT WITHOUT INCIDENT. FRESENIUS KABI CONDUCTED A THOROUGH REVIEW OF BATCH DATA AND RETAINED SAMPLE EVALUATIONS. BASED ON THIS ANALYSIS, FRESENIUS KABI DID NOT IDENTIFY ANY EVIDENCE INDICATING THAT THE REPORTED CONTAMINATION ORIGINATED FROM FRESENIUS KABI PRODUCT OR FRESENIUS KABI MANUFACTURING FACILITIES. FRESENIUS KABI MARICAO PRELIMINARY INVESTIGATION CONCLUSION: BASED ON THE BATCH DATA AND RETAINED SAMPLE EVALUATION MENTIONED ABOVE, THE REPORTED CONTAMINATION WAS NOT CONFIRMED AS ORIGINATING FROM OUR PRODUCT. FURTHERMORE, FOR THE CONTAMINATION TO HAVE OCCURRED DURING MANUFACTURING, THE BACTERIA WOULD NEED TO BE PRESENT IN THE MARICAO CLEAN ROOM DURING THE AMICUS OR INTERSOL MANUFACTURING PROCESS, WOULD NEED TO ENTER THE PRODUCT, AND WOULD NEED TO SURVIVE THE THERMAL STEAM STERILIZATION. NOTE THAT THE MIXING VESSELS ARE A CLOSED SYSTEM AFTER SANITATION, AND EQUIPPED WITH A DOUBLE 0.45 ¿M FILTER, WHICH IS TESTED FOR INTEGRITY BEFORE AND AFTER EACH BATCH. BIOBURDEN TESTING IS CONDUCTED FOR EACH LOT, AND ALL COLONIES ARE IDENTIFIED. PAENIBACILLUS SP WAS NOT IDENTIFIED AS PART OF THE BIOBURDEN PROCESS FOR THESE BATCHES. NOTABLY, CO-COMPONENTS ASSOCIATED WITH THE PLATELET UNIT WERE TRANSFUSED WITHOUT INCIDENT. ACCORDINGLY, TO THIS POINT, WE HAVE FOUND NO EVIDENCE THAT THE CONTAMINATION COULD HAVE ORIGINATED FROM OUR SITE. PRELIMINARY ARC INVESTIGATION SUMMARY: POSSIBLE TRANSFUSION TRANSMITTED SEPSIS BASED ON CLINICAL AND LAB DATA. DONOR HAS NO SYMPTOMS OF INFECTION, OR RISK FACTORS. THERE WERE NO ISSUES DURING MANUFACTURING. WHILE THIS IS A CLINICAL DIAGNOSIS, THESE FINDINGS ARE NOT SUPPORTIVE. THE INVESTIGATION IS STILL ON GOING AT ARC AND CERUS BUT IT CURRENTLY APPEARS THEIR PRELIMINARY FINDINGS AGREE TO INDICATE THAT THE CONTAMINATION OCCURRED OUTSIDE FRESENIUS KABI MANUFACTURING.

    Description of Event or Problem · 0

    NO KIT SAMPLE OR PICTURE WAS AVAILABLE FOR ANALYSIS. ALTHOUGH THERE IS NO PICTURE OR SAMPLE AVAILABLE, THE COMPLAINT IS CONFIRMED DUE TO THE CRITICALITY OF THE DEFECT AND AN INTERNAL INVESTIGATION WAS OPENED TO ADDRESS THIS ISSUE. PAENIBACILLUS WAS NOT IDENTIFIED IN THE PRODUCT BIOBURDEN TEST AT THE HAINA PRODUCTION FACILITY. SIMILARLY, PAENIBACILLUS WAS NOT IDENTIFIED IN THE MANUFACTURING AREAS IN WHICH THE MARICAO PRODUCED PRODUCTS WERE DIRECTLY EXPOSED. THE MICROORGANISM WAS NOT RECOVERED IN MARICAO ON THE DAY OR WITHIN THE MONTH OF MANUFACTURE FOR THE INVOLVED PRODUCTS. ALL BATCH REVIEWS RELATED TO THIS INCIDENT WERE PERFORMED WITH SATISFACTORY RESULTS. NO ISSUES WERE IDENTIFIED DURING THE BATCH REVIEWS THAT COULD CONTRIBUTE TO THE REPORTED ISSUE. THE FOLLOWING CURRENT CONTROLS ARE IN PLACE TO ASSURE THE INTEGRITY OF THE KIT AT THE MANUFACTURING SITE 1) MICROBIOLOGY MONITORING, 2) PRODUCT E-BEAM STERILIZATION, 3) IN PROCESS SAMPLING QUALITY INSPECTION, 4) POST STERILIZATION SAMPLING FINAL INSPECTION. NO ADDITIONAL CONTAMINATION COMPLAINTS HAVE BEEN RECEIVED FOR THE PRODUCTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105800 AMICUS DOUBLE NEEDLE ADVANCED KIT WITH PLATELET ADDITIVE SOLUTION CONNECTOR FOR COLLECTION OF PLATELETS WITH OPTIONAL PLASMA. FOR PLATELET STORAGE IN PLASMA GKT FENWAL INTERNATIONAL INC. 4R2352 FA24G19148 00810020440713

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other