Trima Accel® 82470Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05020583824706), received between Dec 11, 2018 and Jun 19, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Adverse 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 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 RED BLOOD CONTAMINATION DURING PAS ADDITION. 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. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22292680 ↗
• MalfunctionMay 20, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT A TRIMA RED BLOOD CELL (RBC) PRODUCT HAS BEEN IDENTIFIED WITH HEMOLYSIS PRESENT DURING STORAGE. NO PATIENT (DONOR) WAS CONNECTED AT THE TIME OF THE EVENT, THEREFORE, NO PATIENT INFORMATION IS AVAILABLE. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. DONOR UNIT NUMBER:(B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354668 ↗
• MalfunctionMay 20, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT A TRIMA RED BLOOD CELL (RBC) PRODUCT HAS BEEN IDENTIFIED WITH HEMOLYSIS PRESENT DURING STORAGE. NO PATIENT (DONOR) WAS CONNECTED AT THE TIME OF THE EVENT, THEREFORE, NO PATIENT INFORMATION IS AVAILABLE. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. DONOR UNIT #: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354614 ↗
• MalfunctionMay 20, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT A TRIMA RED BLOOD CELL (RBC) PRODUCT HAS BEEN IDENTIFIED WITH HEMOLYSIS PRESENT DURING STORAGE. NO PATIENT (DONOR) WAS CONNECTED AT THE TIME OF THE EVENT; THEREFORE, NO PATIENT INFORMATION IS AVAILABLE. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. DONOR UNIT #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354540 ↗
• MalfunctionMay 20, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT A TRIMA RED BLOOD CELL (RBC) PRODUCT HAS BEEN IDENTIFIED WITH HEMOLYSIS PRESENT DURING STORAGE. NO PATIENT (DONOR) WAS CONNECTED AT THE TIME OF THE EVENT; THEREFORE, NO PATIENT INFORMATION IS AVAILABLE. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. DONOR UNIT #:(B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354193 ↗
• MalfunctionMay 20, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT A TRIMA RED BLOOD CELL (RBC) PRODUCT HAS BEEN IDENTIFIED WITH HEMOLYSIS PRESENT DURING STORAGE. NO PATIENT (DONOR) WAS CONNECTED AT THE TIME OF THE EVENT, THEREFORE, NO PATIENT INFORMATION IS AVAILABLE. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. DONOR UNIT NUMBER:(B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354122 ↗
• MalfunctionFeb 6, 2024Adverse 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 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. AFTER A SECOND FILTRATION THE PRODUCT WAS CONTROLLED AGAIN AND THE RESULT OF WBCS WAS 0. 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. 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 18651002 ↗
• MalfunctionApr 20, 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 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 WBC 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16777097 ↗
• MalfunctionNov 21, 2022Contamination 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. WBC COUNT IS NOT AVAILABLE. 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. 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 15835657 ↗
• InjuryNov 21, 2022Adverse 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 AROUND 40 MINUTES INTO A DONOR'S FIRST APHERESIS DONATION, THE DONOR PRESENTED WITH GENERAL MALAISE, "BURNING WITH INSPIRATION", RESPIRATORY DIFFICULTY, RASH THAT STARTED IN THE THORAX AND SPREAD TO THE NECK AND UPPER LIMBS. THE DONATION WAS SUSPENDED. THE EMERGENCY SYSTEM WAS ACTIVATED AND A FEW MINUTES LATER THE DONOR WAS TREATED WITH CRYSTALLOIDS, ADRENALINE IM 1MG, DEXAMETHASONE IM 8MG AND HYDROCORTISONE IV 300MG AND SHOWED IMPROVEMENT IN SYMPTOMS. SHE WAS TRANSFERRED TO THE HEALTH CENTER, UNDER THE DIAGNOSTIC IMPRESSION OF ANAPHYLACTIC REACTION. PER THE CUSTOMER, THE PATIENT IS STABLE AND IN GOOD GENERAL CONDITION WITHOUT SEQUELAE. NO ISSUES WERE NOTED WITH THE PROCEDURE. FULL PATIENT ID: CC (B)(6) THE SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15835208 ↗
• MalfunctionOct 15, 2020Adverse 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 RED BLOOD CELL (RBC) 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.

  Patient problems: No Patient Involvement

  MAUDE report 10684470 ↗
• MalfunctionMar 22, 2019Use of Device Problem; Obstruction of Flow; Use of Device Problem

  THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION AND PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8443904 ↗
• MalfunctionDec 11, 2018Adverse 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 BLOODCELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT NO: (B)(6) THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Patient Involvement

  MAUDE report 8151707 ↗