Trima Accel® 80410Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05020583804104), received between Oct 19, 2018 and Dec 13, 2024 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. RED BLOOD WAS MIXED IN PLATELET CONTAINER DURING ADDITIVE SOLUTION ADDITION. NO ALARMS WAS GENERATED BY TRIMA BEFORE OR AFTER CONTAMINATION OF PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. WBC COUNT IS UNKNOWN AT THIS TIME. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925509 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT A PATIENT HAD AN ALLERGIC TRANSFUSION REACTION AFTER THEY WERE TRANSFUSED WITH PLATELET PRODUCTS COLLECTED ON TRIMA. THE PRODUCT WAS COLLECTED ON (B)(6) 2023 (PAS), AND TRANSFUSED ON (B)(6) 2023. THE CUSTOMER DECLINED TO PROVIDE PROCEDURAL DETAILS, PATIENT INFORMATION, AND PATIENT OUTCOME. THE SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16599407 ↗
• MalfunctionDec 27, 2021Contamination of Device Ingredient or Reagent; No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE RED BLOOD CELL (RBC) PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(6) WBC COUNT IS NOT AVAILABLE AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087970 ↗
• MalfunctionDec 20, 2021Contamination of Device Ingredient or Reagent; No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE OVERFLOW INTO THE PLATELET CONCENTRATE WHEN THE ADDITIVE SOLUTION WAS ADDED. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. WBC COUNT IS NOT AVAILABLE AT THIS TIME. THE DISPOSABLES SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048348 ↗
• MalfunctionFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE PLATELET PRODUCT BEING RED. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THE WBC COUNT IS NOT AVAILABLE, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11358242 ↗
• MalfunctionDec 21, 2020Excess Flow or Over-Infusion; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE OVERFLOW INTO THE PLATELET CONCENTRATE WHEN THE ADDITIVE SOLUTION WAS ADDED. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THE WBC COUNT IS NOT AVAILABLE, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11046216 ↗
• MalfunctionSep 4, 2020Excess Flow or Over-Infusion; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE OVERFLOW INTO THE PLATELET CONCENTRATE WHEN THE ADDITIVE SOLUTION WAS ADDED. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. WBC COUNT IS NOT AVAILABLE AT THIS TIME. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Patient Involvement

  MAUDE report 10494579 ↗
• MalfunctionJun 15, 2020No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS CONFIRMED BY THE CUSTOMER DURING FOLLOW-UP THAT NO MEDICAL INTERVENTION WAS REQUIRED FOR THE ALLERGIC REACTION AND THE CUSTOMER FINISHED THE COLLECTION PROCESS.

  Patient problems: Hypersensitivity/Allergic reaction; No Known Impact Or Consequence To Patient; Skin Discoloration

  MAUDE report 10153510 ↗
• MalfunctionFeb 3, 2020High Test Results; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Patient Involvement

  MAUDE report 9660657 ↗
• MalfunctionFeb 3, 2020High Test Results; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Patient Involvement

  MAUDE report 9660300 ↗
• MalfunctionMar 26, 2019High Readings; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(6). THE WBC COUNT IS NOT AVAILABLE AT THIS TIME. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Patient Involvement

  MAUDE report 8452227 ↗
• InjuryOct 19, 2018Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT DURING A TRIMA COLLECTION PROCEDURE, THE "SHIRT" OF THE TUBING OF THE DISPOSABLE SET DETACHED ITSELF, "DIRTING" THE NURSE. PER THE CUSTOMER, BOTH EYES AND THE MOUTH MUCUS MEMBRANE WERE SPATTERED ONTO THE NURSE AND THE NURSE WENT TO THE EMERGENCY ROOM. PATIENT ID, GENDER, WEIGHT AND OUTCOME ARE UNAVAILABLE AT THIS TIME. TERUMO BCT IS AWAITING THE RETURN OF THE TRIMA COLLECTION SET.

  Patient problems: Exposure to Body Fluids; No Known Impact Or Consequence To Patient

  MAUDE report 7985163 ↗