Trima Accel® 80520Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05020583805200), received between Mar 29, 2019 and Mar 5, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (1 report).

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

• MalfunctionMar 5, 2021Adverse Event Without Identified Device or Use Problem; High Test Results; 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 A 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. DONOR UNIT #: (B)(4). 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 11425668 ↗
• MalfunctionJul 29, 2020Incorrect, Inadequate or Imprecise Result or 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 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. DONOR UNIT #: (B)(6). THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Patient Involvement

  MAUDE report 10338312 ↗
• MalfunctionApr 5, 2019Device Alarm System; Use of Device Problem; Inadequate User Interface; Use of Device Problem; Inadequate User Interface

  THE CUSTOMER REPORTED THAT DURING AN AUTO REDO BLOOD CELL (RBC) PLASMA DONATION PROCEDURE ON TRIMA, THE OPERATOR ATTACHED AS-3 TO THE SALINE LINE IN ERROR. THE DEVICE DID NOT DETECT THE ERROR UNTIL THE TRIMA HAD TRANSFUSED APPROXIMATELY 200 ML OF AS-3 DURING SALINE RETURN. THE OPERATOR WAS ALERTED TO THE ISSUE WHEN THE TRIMA HAD A LEVEL SENSOR ERROR DUE TO THE AS-3 BAG BEING EMPTY. FULL DONOR IDENTIFIER: (B)(6). THE DONOR WAS RELEASED WITH NO SIDE EFFECTS FOLLOWING THE DONATION. THE CUSTOMER FOLLOWED UP THE FOLLOWING DAY TO REPORT THE DONOR SUFFERED NO ILL EFFECTS FROM THE DONATION. THE CUSTOMER DECLINED TO PROVIDE THE DONOR'S AGE. THE PLASMA RBC COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8488020 ↗
• MalfunctionMar 29, 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 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. DONOR UNIT #: (B)(4). THE RBC COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Patient Involvement

  MAUDE report 8464464 ↗