Trima Accel® 82408Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05020583824089), received between Jul 9, 2019 and Dec 6, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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.

• MalfunctionDec 6, 2019Adverse Event Without Identified Device or Use Problem; Defective Component; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT WHILE SETTING UP THE TRIMA DEVICE IT WAS FOUND THAT THE WHITE PINCH CLAMP WAS DEFECTIVE ON THE SAMPLE POUCH LINE. PER THE CUSTOMER THE DISPOSABLE SET WAS NOT USED. NO PATIENT (DONOR) WAS CONNECTED AT THE TIME OF THE EVENT, THEREFORE, NO PATIENT INFORMATION IS AVAILABLE. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Patient Involvement

  MAUDE report 9429574 ↗
• MalfunctionAug 9, 2019Inflation Problem; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DURING THE LOADING OF THE TUBING SET ON THE TRIMA MACHINE FOR AN ALLOGENEIC PLATELET DONATION, THEY RECEIVED AIR DETECTED ALARMS AND THE SAMPLE BAG INFLATED WITH AIR. PER THE CUSTOMER, ALL CLAMPS WERE CLOSED AND NO OBVIOUS HOLES WERE DETECTED IN THE DISPOSABLE TUBING. THERE WAS NO DONOR CONNECTED FOR THIS EVENT, THEREFORE NO DONOR INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8879117 ↗
• MalfunctionJul 9, 2019Adverse Event Without Identified Device or Use Problem; Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem

  THERE WAS NO DONOR CONNECTED FOR THIS EVENT, THEREFORE NO DONOR INFORMATION IS REASONABLYKNOWN AT THE TIME OF THE EVENT.CORRECTION: PATIENT GENDER AND WEIGHT INFORMATION PROVIDED IN THE INITIAL MDR ARE NO LONGERRELEVENT TO THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8771973 ↗