Trima Accel® 82700Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05020583827004), received between Nov 8, 2019 and Feb 12, 2021 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Misassembled” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2021Misassembled; Misassembled; Improper or Incorrect Procedure or Method

  LOW HEMATORCRIT RED BLOOD CELLS WERE COLLECTED INSTEAD OF PLASMA FROM THE DONOR. NO CLINICAL CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11321326 ↗
• MalfunctionFeb 11, 2021Misassembled

  THE SET WAS NOT USED, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN. PATIENT GENDER AND WEIGHT INCLUDED IN A.3 AND A.4 DUE TO SYSTEM LIMITATION AND ARE NOT RELEVANT TO THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11317369 ↗
• MalfunctionDec 9, 2020Fluid/Blood Leak; Misassembled; Misassembled

  THE CUSTOMER DECLINED TO PROVIDE PATIENT (DONOR) AGE, SEX, OR WEIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10976747 ↗
• MalfunctionDec 2, 2020Leak/Splash; Increase in Pressure; Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THAT DURING A PLASMAPHERESIS PROCEDURE THEY FOUND THAT THE SET WAS DEFECTIVE. DURING PLASMA COLLECTION, THEY RECEIVED A CENTRIFUGE PRESSURE HIGH ALARM AND THE CUSTOMER FOLLOWED PROMPTS ON TRIMA TO ASSESS POSSIBLE ISSUES. THE CUSTOMER FOUND THAT THERE WAS AIR BEING PULLED INTO THE LINES JUST ABOVE THE MANIFOLD WHERE THE SINGLE TUBING FROM THE DONOR TO THE MANIFOLD CONNECT. THERE WAS ALSO BLOOD DRIPPING FROM THIS SAME PLACE. THE COLLECTION WAS DISCONTINUED WITHOUT RINSEBACK. A DIAGRAM FROM CUSTOMER INDICATED THE LEAK WAS AT THE 3-1 MANIFOLD. PER THE CUSTOMER NO SERIOUS INJURY OCCURED AND NO MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. PATIENT INFORMATION AND OUTCOME ARE NOT AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10935874 ↗
• MalfunctionNov 9, 2020Adverse Event Without Identified Device or Use Problem; Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT FOLLOWING AN APHERESIS PLASMA COLLECTION ON THE TRIMA DEVICE, THE COLLECTION MEASURED 937ML, WHICH WAS OVER THE LIMIT FOR THIS COLLECTION AND MORE PLASMA VOLUME WAS COLLECTED THAN EXPECTED. THEY HAD MORE THAN ONE PERSON VERIFY THE WEIGHT, CONVERSION, AND TARES TO ENSURE IT WAS DONE APPROPRIATELY. PREDICTED VOLUME WAS 825 ML. MEASURED VOLUME WAS 937ML. TBV IS 5389 X 15% TBV = 808.35 ML - 109 AC = 709 ML TOTAL VOLUME COLLECTED. FULL PATIENT (DONOR) IDENTIFIER: (B)(6). PATIENT AGE IS NOT AVAILABLE AT THIS TIME. THE DONOR EXPERIENCED NO ADVERSE EFFECTS FROM THIS PROCEDURE. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10809358 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER DID NOT RESPOND TO ATTEMPTS TO OBTAIN THE PATIENT (DONOR) AGE. PER THE CUSTOMER IT WAS A SUPERFICIAL CLOT AND NO ANTICOAGULANTS WERE NEEDED. THE DONOR HAS BEEN BACK TO DONATE PLASMA MANY TIMES SINCE WITH NO ISSUES.

  Patient problems: Thrombosis

  MAUDE report 10515421 ↗
• MalfunctionNov 8, 2019Use of Device Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Misassembly by Users

  THE CUSTOMER REPORTED THAT DURING A TRIMA DONATION THE OPERATOR SWITCHED THE ANTICOAGULANTCITRATE DEXTROSE SOLUTION A(ACD-A) AND SALINE BAGS. THE PROCEDURE WAS RUN FOR 13 MINUTES, ATTHIS POINT THE OPERATOR REALIZED THE ERROR AND DISCONNECTED THE DONOR. PER THE CUSTOMER THE DONOR WAS RELEASED ON THEIR BEHALF. STANDARD TREATMENT FOLLOWING ANORMAL DONATION WAS PROVIDED (I.E. REFRESHMENTS AND REMAINING IN THE CANTEEN FOR A SHORT TIME). NO FURTHER TREATMENT WAS PERFORMED. THE DONOR WAS REPORTED AS FINE AFTER THE PROCEDURE. FULL PATIENT IDENTIFIER: (B)(6). THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9295723 ↗