Trima Accel® 80340Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05020583803404), received between Mar 6, 2019 and Nov 1, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2019Device Displays Incorrect Message; Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER MULTIPLE FOLLOW-UP ATTEMPTS, THE CUSTOMER DID NOT PROVIDE FURTHER DETAILS FOR THIS EVENT, INCLUDING SPECIFIC DATE AND TIME.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9266363 ↗
• MalfunctionApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN OPERATOR WAS USING THE SEAL SAFE ON THE TRIMA MACHINE POST PLATELET COLLECTION TO DISCONNECT THE PLASMA BAG FROM THE SET. THE SEAL THAT WAS CREATED WAS REPORTED AS "POOR" AND BROKE, CAUSING PLASMA TO SPRAY INTO THE EYES OF THE OPERATOR. IMMEDIATELY POST EXPOSURE, THE OPERATOR COMPLETED A 15 MINUTE EYE WASH. THE OPERATOR AND THE DONORS BLOOD WERE TESTED POST EXPOSURE AND ALL RESULTS FOR (B)(6) WERE (B)(6). THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8469874 ↗
• MalfunctionMar 6, 2019Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  THE CUSTOMER REPORTED EXCESSIVE AMOUNT OF AIR IN THE SAMPLE BAG PRIOR TO PHLEBOTOMY OF THE DONOR. PER THE RN, PRE-PHLEBOTOMY OF THE DONOR SHE NOTICED THAT THE SAMPLE BAG WAS FILLED WITH AIR. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THIS INCIDENT AS THE REPORTED ISSUE WAS DETECTED PRIOR TO STARTING THE PROCEDURE, THEREFORE NO PATIENT/RECIPIENT INFORMATION IS REPORTED FOR THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8395192 ↗