Fenwal AMICUS Double Needle Advanced Kit 4R2354Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04086000101387), received between Sep 27, 2019 and Aug 4, 2020 — classified as 1 injury, 3 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER (AMERICAN RED CROSS ARC) REPORTED :AMICUS PLATELET COLLECTED ON 06/20/2020 (EXP. 06/25/2020), AMICUS LOT FA20D28132. COLLECTED IN FACILITY 018, MANUFACTURED IN FACILITY 016. TWO PLATELET PRODUCTS FROM THIS DONATION, PCODE E7002V00 WAS DISTRIBUTED TO A HOSPITAL IN (B)(6) AND WAS TRANSFUSED WITHOUT INCIDENT. PRODUCT E7003V00 WAS SHIPPED TO A HOSPITAL IN (B)(6) FOLLOWING A SITE TO SITE SHIPMENT FROM (B)(6). BACT TESTING WAS NEGATIVE AFTER 5 DAYS, HOSPITAL VERBALLY REPORTED A SEPTIC TRANSFUSION REACTION TO DCSC ON (B)(6) 2020. ON 06/30/2020, DCSC WAS NOTIFIED PATIENT POST TRANSFUSION CULTURE AND RESIDUAL PRODUCT CULTURES ARE POSITIVE FOR ACINETOBACTER HAEMOLYTICUS. THIS NOT A FATALITY. ARC INTERNAL NUMBER IS (B)(4). FROM ARC: THE PLATELET WAS COLLECTED BY (B)(6) REGION. TWO PLATELETS (CO-COMPONENTS) WERE MANUFACTURED BY (B)(6) REGION - 1 CO-COMPONENT WAS TRANSFUSED IN (B)(6) REGION HOSPITAL WITHOUT INCIDENT AND 1 CO-COMPONENT WAS SHIPPED TO (B)(6) REGION AND TRANSFUSED IN A (B)(6) HOSPITAL WHICH REPORTED THE TRANSFUSION REACTION.

  Patient problems: Reaction to Medicinal Component of Device; Sepsis

  MAUDE report 10364376 ↗
• MalfunctionSep 27, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED THE UNIT COLLECTED DURING DONATION TESTED POSITIVE FOR PROPIONIBACTERIUM ACNES(A). THE MICROORGANISMS WERE FOUND IN THE PLATELET STORAGE BAGS. THE TIME INTERVAL THAT THESE MICROORGANISMS WERE FOUND WAS 4.5 DAYS. DOUBLE PRODUCT; NO BAG ATTACHED; SAMPLING DEVICE STERILE WELDED. INVESTIGATION 599817 WAS COMPLETED. NO SAMPLES WERE RECEIVED FOR ANALYSIS. HOWEVER, MICROBIOLOGICAL TESTING RESULTS WERE REVIEWED FOR AMICUS BATCH FA19E06138 MANUFACTURING PERIOD, INCLUDING PREVIOUS MONTH. NO OUT OF LIMIT IS OBSERVED IN THE 12-MONTH TIMEFRAME. A MICROBIOLOGY TESTING EXTERNAL SUPPLIER, PACE ANALYTICAL, COMPLETED ADDITIONAL TESTING TO THE AMICUS MANUFACTURING AREAS, INCLUDING THE FOLLOWING SAMPLING: - ENVIRONMENTAL MONITORING AIR SAMPLES - SURFACE MONITORING SWABS - ORGANISM IDENTIFICATION THE SAME SAMPLING WAS TAKEN BY THE HAINA MICROBIOLOGY LAB TEAM, TO REVIEW THE CURRENT AMICUS CONDITIONS. ROOT CAUSE IDENTIFIED: THE AMICUS MICROBIOLOGY TESTING WAS COMPLETED WITH SATISFACTORY RESULTS. THE BACTERIA IDENTIFIED BY THE CUSTOMER IS NOT PART OF THE HAINA PLANT MICRO-FLORA. IN ADDITION, THE MICROBIOLOGY MONITORING IS WITHIN ESTABLISHED LIMIT. CURRENT CONTROLS: - MICROBIOLOGY MONITOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9130455 ↗
• MalfunctionSep 27, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED THE UNIT COLLECTED DURING DONATION TESTED POSITIVE FOR GRAM+ RODS RESEMBLING BACILLUS. THE MICROORGANISMS WERE FOUND IN THE PLATELET STORAGE BAGS. THE TIME INTERVAL THAT THESE MICROORGANISMS WERE FOUND WAS 17.2 HOURS. SINGLE PRODUCT; NO BAG ATTACHED; SAMPLING DEVICE STERILE WELDED. INVESTIGATION 599817 WAS COMPLETED. NO SAMPLES WERE RECEIVED FOR ANALYSIS. HOWEVER, MICROBIOLOGICAL TESTING RESULTS WERE REVIEWED FOR AMICUS BATCH FA19E06138 MANUFACTURING PERIOD, INCLUDING PREVIOUS MONTH. NO OUT OF LIMIT IS OBSERVED IN THE 12-MONTH TIMEFRAME. A MICROBIOLOGY TESTING EXTERNAL SUPPLIER, PACE ANALYTICAL, COMPLETED ADDITIONAL TESTING TO THE AMICUS MANUFACTURING AREAS, INCLUDING THE FOLLOWING SAMPLING: - ENVIRONMENTAL MONITORING AIR SAMPLES. - SURFACE MONITORING SWABS. - ORGANISM IDENTIFICATION. THE SAME SAMPLING WAS TAKEN BY THE HAINA MICROBIOLOGY LAB TEAM, TO REVIEW THE CURRENT AMICUS CONDITIONS. ROOT CAUSE IDENTIFIED: THE AMICUS MICROBIOLOGY TESTING WAS COMPLETED WITH SATISFACTORY RESULTS. THE BACTERIA IDENTIFIED BY THE CUSTOMER IS NOT PART OF THE HAINA PLANT MICRO-FLORA. IN ADDITION, THE MICROBIOLOGY MONITORING IS WITHIN ESTABLISHED LIMIT. CURRENT CONTROLS: - MICROBIOLOG

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9130454 ↗
• MalfunctionSep 27, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED THE UNIT COLLECTED DURING DONATION TESTED POSITIVE FOR LISTERIA MONOCYTOGENES (AA). THE MICROORGANISMS WERE FOUND IN THE PLATELET STORAGE BAGS. THE TIME INTERVAL THAT THESE MICROORGANISMS WERE FOUND WAS 16.9 HOURS. TRIPLE PRODUCT; BAG ATTACHED; SAMPLING DEVICE STERILE WELDED. INVESTIGATION 599817 WAS COMPLETED. NO SAMPLES WERE RECEIVED FOR ANALYSIS. HOWEVER, MICROBIOLOGICAL TESTING RESULTS WERE REVIEWED FOR AMICUS BATCH FA19E06138 MANUFACTURING PERIOD, INCLUDING PREVIOUS MONTH. NO OUT OF LIMIT IS OBSERVED IN THE 12-MONTH TIMEFRAME. A MICROBIOLOGY TESTING EXTERNAL SUPPLIER, PACE ANALYTICAL, COMPLETED ADDITIONAL TESTING TO THE AMICUS MANUFACTURING AREAS, INCLUDING THE FOLLOWING SAMPLING: - ENVIRONMENTAL MONITORING AIR SAMPLES - SURFACE MONITORING SWABS - ORGANISM IDENTIFICATION THE SAME SAMPLING WAS TAKEN BY THE HAINA MICROBIOLOGY LAB TEAM, TO REVIEW THE CURRENT AMICUS CONDITIONS. ROOT CAUSE IDENTIFIED: THE AMICUS MICROBIOLOGY TESTING WAS COMPLETED WITH SATISFACTORY RESULTS. THE BACTERIA IDENTIFIED BY THE CUSTOMER IS NOT PART OF THE HAINA PLANT MICRO-FLORA. IN ADDITION, THE MICROBIOLOGY MONITORING IS WITHIN ESTABLISHED LIMIT. CURRENT CONTROLS: - MICROBIOLOGY MONITOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9130453 ↗