Amicus Double Needle Advanced Kit with Platelet Additive Solution Connector 4R2352Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810020440713), received between Nov 27, 2024 and Dec 10, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Microbial Contamination of Device; Microbial Contamination of Device

  FRESENIUS KABI HAINA INVESTIGATION CONCLUSION: NO SAMPLE OR IMAGE AVAILABLE FOR ANALYSIS. ALTHOUGH THERE IS NO IMAGE OR SAMPLE AVAILABLE, THE COMPLAINT IS CONFIRMED DUE TO THE CRITICALITY OF THE DEFECT AND AN INTERNAL INVESTIGATION WAS OPENED TO ADDRESS THIS ISSUE. A COMPREHENSIVE TREND ANALYSIS OF BIOBURDEN TESTING DATA COLLECTED BETWEEN (B)(6) 2024 AND (B)(6) 2025 DEMONSTRATED THAT NO OUT OF LIMIT {OOL) RESULTS WERE IDENTIFIED FOR THE AMICUS AND PRODUCT IN PROCESS (PIP) PRODUCT CATEGORIES. A MICROORGANISM TREND ANALYSIS WAS CONDUCTED FROM (B)(6) 2025. NO STAPHYLOCOCCUS SPECIES WERE DETECTED IN THE BIOBURDEN TESTING OF EITHER AMICUS OR PRODUCT IN PROCESS {PIP) PRODUCT CATEGORIES. HOWEVER, DURING THE ENVIRONMENTAL AND WATER MONITORING PERFORMED WITHIN THE SAME PERIOD, STAPHYLOCOCCUS EPIDERMIDIS WAS IDENTIFIED IN MICROBIOLOGICAL SURFACE AND WATER SAMPLES FROM CLEAN ROOM #1 ON DECEMBER 2024 AND JUN 2025. THEREFORE, THE CUSTOMER COMPLAINT IS CONFIRMED. TO ENSURE A THOROUGH ANALYSIS, AN INTERNAL INVESTIGATION HAS BEEN INITIATED TO ADDRESS THIS DEFECT AND IDENTIFY ANY POTENTIAL ROOT CAUSES AND CORRECTIVE ACTIONS. TO ASSURE THE INTEGRITY OF THE KIT, THE FOLLOWING CONTROLS ARE ESTABLISHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771118 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FRESENIUS KABI HAINA INVESTIGATION CONCLUSION: 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. A MICROORGANISM TREND WAS CONDUCTED FROM (B)(6) 2024 TO (B)(6) 2025 AND NO ACINETOBACTER SPECIES WERE DETECTED IN THE PRODUCT BIOBURDEN TEST OF AMICUS OR PRODUCT IN PROCESS. THE ENVIRONMENTAL TEST TREND WAS CONDUCTED FROM (B)(6) 2024 TO (B)(6) 2025 AND NOT OUT OF ALERT LIMITS WERE IDENTIFIED IN THE SURFACE AND AIR TEST IN AMICUS AND PRODUCT PROCESS. 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, 5) THE FIRST PIECE INSPECTION WILL BE PERFORMED TO THE FIRST FINAL ASSEMBLED KIT MANUFACTURED PER SHIFT. THIS KIT WILL BE SUBMITTED

  Patient problems: Transfusion Reaction

  MAUDE report 23487402 ↗
• MalfunctionJun 25, 2025Microbial Contamination of Device; Microbial Contamination of Device

  PER THE ARC CAPA QUALITY ENGINEER, SUPPLIER QUALITY: I WANTED TO LET YOU KNOW THAT I OPENED A NEW NSEPD TODAY ASSOCIATED WITH A POSITIVE BACT CASE WHICH WAS DETERMINED TO BE REPORTABLE TO THE FDA AS A POLYMICROBIAL POSITIVE (2 OR MORE BACTERIAL SPECIES) WAS DETECTED IN THE BACTERIAL TESTING OF A PLATELET COLLECTION. THE TWO ORGANISMS IDENTIFIED WERE: STAPHYLOCOCCUS EPIDERMIDIS AND STAPHYLOCOCCUS HOMINIS. THIS UNIT WAS COLLECTED (B)(6) 2025 AT THE COLUMBIA SC BLOOD DONATION CENTER, LOT NUMBER FA24K07193. THE INVOLVED PHLEBOTOMIST SUBSEQUENTLY WAS OBSERVED FOLLOWING PROPER ARM SCRUB PROCEDURES. THERE ARE NO SAMPLES AVAILABLE. FRESENIUS KABI HAS COMPLETED THE FOLLOWING INVESTIGATIONS. 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. ALL RETENTION SAMPLE REVIEWS RELATED TO THIS INCIDENT WERE PERFORMED WITH SATISFACTORY RESULTS. NO ISSUES WERE IDENTIFIED DURING THE RETENTION SAMPLE REVIEWS THAT COULD CONTRIBUTE TO THE REPORTED ISSUE. NO ADDITIONAL POSITIVE BACT COMPLAINTS HAVE BEEN RECEIVED FOR THE REPORTED AMICUS KIT BATCH FA24K07193. BASED ON THIS ANALYSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329084 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FURTHER EVALUATION REVEALED THE AMICUS CELL SEPARATOR MATERIAL CODE 4R4580, SERIAL NUMBER (B)(6) WAS INVOLVED WITH THIS EVENT. NO SAMPLE OR PICTURE WAS RETURNED FOR THE AMICUS CELL SEPARATOR. THE CUSTOMER CONTACTED THE SERVICE TEAM FOR INFORMATION THAT RESULTED IN A SERVICE REPAIR BEING REQUIRED ON THE DEVICE. THE FOLLOWING IS THE LIST OF SERVICE ACTIVITIES CARRIED OUT BY FSE (FIELD SERVICE ENGINEER): 1) THE FSE STATED REPLACEMENT OF BATTERY, UTILITY BOARD AND GASKET KIT, 2) THE DEVICE(S) SUCCESSFULLY UNDERWENT CORRECTIVE MAINTENANCE ACCORDING TO THE MANUFACTURER'S RECOMMENDATIONS, 3) THE DEVICE PASSED ALL TESTS AFTER REPAIR. A REVIEW OF THE SERVICE RECORDS FOR THIS DEVICE, SERIAL NUMBER (B)(6), BETWEEN (B)(6) 2023, OR 24 MONTHS PRIOR TO THE NOTIFICATION DATE OF THIS COMPLAINT RECORD, WHICHEVER IS SHORTER, FOUND NO SAME/SIMILAR COMPLAINTS RELATED TO THIS ONE. THE DEVICE HISTORY REVIEW (DHR) FOR SN (B)(6) WAS PERFORMED BY REVIEWING ALL AVAILABLE RESOURCES INCLUDING BUT NOT LIMITED TO: SMARTSOLVE SEARCH AS WELL AS ANY LOCALLY SCANNED OR PHYSICAL COPIES RETAINED BY FRESENIUS KABI SITES. THE DHR HAS BEEN DETERMINED TO BE UNAVAILABLE, BUT THE INVESTIGATION IS PERMITTED TO PROCEED AS DET

  Patient problems: Low Blood Pressure/ Hypotension; Malaise

  MAUDE report 21875528 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 ASSEM

  Patient problems: Chills

  MAUDE report 21096343 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1 CERUS PLT CONTAINER (B)(4) WAS RECEIVED BY FRESENIUS KABI FROM THE AMERICAN RED CROSS FOR EVALUATION. THE SAMPLE WAS A USED PLATELET CONTAINER WITH ATTACHED ADMINISTRATION SET. THE FOLLOWING EVALUATION STEPS WERE PERFORMED 1) VISUAL INSPECTION OF THE SAMPLE AND 2) UNDERWATER LEAK TEST. THE CONTAINER WAS RECEIVED WITH APPROXIMATELY 50 ML OF A CLEAR, COLORLESS SOLUTION; AN ADMINISTRATION SET WAS SPIKED INTO THE CENTER SPIKE PORT, AND A SAMPLE SPIKE WAS INSERTED INTO THE SIDE SPIKE PORT. THE ADMIN SET TUBING WAS HEAT SEALED ABOVE THE SPIKE AND THE SET REMOVED FOR EVALUATION OF THE CONTAINER. LIGHT SCUFF MARKS ARE NOTED ON THE FRONT AND BACK SURFACE OF THE CONTAINER, BUT THERE WERE NO SCRATCHES INTO THE WALL OF THE CONTAINER SHEETING. INSPECTION OF THE PERIMETER SEAL AND THE TOP SEAL AROUND THE PORTS REVEALS NO DAMAGE, HOLES OR DEFECTS. NO INCONSISTENCY OF THE SEALS AROUND THE PORTS THAT COULD LEAD TO A CHANNEL LEAK WERE NOTED. NO DAMAGE TO THE PORTS OR TOP OF THE CONTAINER WERE NOTED FROM THE SPIKING OF THE PORTS. THE CONTAINER WAS DECONTAMINATED BY INJECTING 50 ML OF BLEACH, ALLOWING TO SIT FOR 15 MINUTES, AND THEN RINSING WITH DI WATER. THE CONTAINER WAS LEAK TESTED BY PLACING THE

  Patient problems: Chills; Fever; Nausea

  MAUDE report 20801271 ↗