Fenwal AMICUS Apheresis Kit-Double Needle w/Platelet Additive Solution Connector 4R2340Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04086000101325), received between Dec 14, 2018 and Dec 14, 2018 — classified as 1 death, 2 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathDec 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 A

  Patient problems: Death

  MAUDE report 8166393 ↗
• InjuryDec 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 AMERICAN RED CROSS (ARC) 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 EXPERIENCED AN ADVERSE REACTION AT THE HOSPITAL/FACILITY THAT RECEIVED THE PLATELETS FROM AMERICAN RED CROSS (NOT DIRECTLY FROM FRESENIUS KABI). FRESENIUS KABI DOES NOT HAVE THE INFUSED PATIENT'S INFORMATION. PATIENT INFORMATION MAY BE AVAILABLE FROM ANOTHER MDR REPORTED BY THE CERUS CORPORATION WHICH WE BELIEVE TO BE THE SAME INCIDENT. THEIR REPORT NUMBER IS 3003925919-2018-00004. COMPLAINT (B)(4)WAS RECEIVED AGAINST MATERIAL CODE 4R2340, LOT NUMBER FA18A25104. THE CUSTOMER STATES THAT A FACILITY USING THEIR COLLECTED PLATELET PRODUCT EXPERIENCED AN ADVER

  Patient problems: Bacterial Infection

  MAUDE report 8166380 ↗
• InjuryDec 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 AMERICAN RED CROSS (ARC) 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 TWO PATIENTS WHOM EXPERIENCED AN ADVERSE REACTION AT THE HOSPITAL/FACILITY THAT RECEIVED THE PLATELETS (FROM THE SAME DONATION) FROM AMERICAN RED CROSS (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 FA18C26074. THE CUSTOMER STATES THAT A FACILITY USING THEIR COLLECTED PLATELET PRODUCT EXPERIENCED AN ADVERSE REACTION POST PLATELET TRANSFUSION (ASSUMED TO BE DUE TO BACTERIAL CONTAMINATION). NEITHER A SAMPLE NOR PICTURE WERE AVAILABLE FOR FURTHER EVALU

  Patient problems: Bacterial Infection

  MAUDE report 8166374 ↗