Trima Accel® 82416Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05020583824164), received between May 11, 2020 and May 2, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 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 REPORTED THAT DURING A PLATELET PROCEDURE A FIRST TIME AUTOMATION DONOR HAD WHAT APPEARED TO BE AN ALLERGIC REACTION WHILE ON THE DEVICE. THE PATIENT BECAME ITCHY, FLUSHED, AND REPORTED THAT HIS TONGUE WAS SWELLING. THE PROCEDURE WAS STOPPED, 911 WAS CALLED, AND THE DONOR WAS SENT TO THE HOSPITAL VIA AMBULANCE. PER THE CUSTOMER NO MEDICAL INTERVENTION WAS PROVIDED AT THE DONATION CENTER. PER FOLLOW UP FROM THE CUSTOMER, THE DONOR WAS REPORTED AS OKAY. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hot Flashes/Flushes; Itching Sensation; Swelling/ Edema

  MAUDE report 21950927 ↗
• MalfunctionJul 28, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; 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. DONOR UNIT #: (B)(6) 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 17414743 ↗
• MalfunctionJan 16, 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. DONOR UNIT #: (B)(6). 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 16174828 ↗
• MalfunctionJan 12, 2023Material Puncture/Hole; Insufficient Device Problem Information; Material Puncture/Hole; Insufficient Device Problem Information

  THE CUSTOMER REPORTED AIR IN THE TUBING SET DURING AN APHERESIS PLATELET PROCEDURE. SHE REPORTED THE AIR WAS THROUGH THE SET. THE PICTURE PROVIDED BY THE CUSTOMER SHOWS AIR IN THE RETURN LINE AND COMING FROM THE CENTRIFUGE. SHE DID NOT FIND ANY LEAKS. SHE NOTED THE AIR 20 SECONDS AFTER THE FIRST RETURN CYCLE BEGAN. SHE CLAMPED THE RETURN LINE AND STOPPED THE PROCEDURE. NO AIR WAS RETURNED TO THE DONOR, RINSEBACK WAS NOT GIVEN. THE DONOR WAS OBSERVED FOR 15-20 MINUTES AND SHOWED NO ILL SIGNS. DONOR REQUIRED NO MEDICAL INTERVENTION AND LEFT ON THEIR OWN ACCORD. THE CUSTOMER ALSO REPORTED THIS WAS FROM THE 2ND VENIPUNCTURE, ATTACHED NEEDLE DID NOT LEAK. FULL PATIENT ID:(B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16151788 ↗
• MalfunctionJan 5, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE CUSTOMER CALLED TO REPORT THAT THEY HAD A DATA ENTRY ERROR. THE OPERATOR INADVERTENTLY ENTERED THE DONORS HEIGHT AS 6'9" FOR A DOUBLE PLATELET DONATION. THE DONORS ACTUAL HEIGHT IS 5'9" . THE ERROR WAS CAUGHT DURING RECORD REVIEW AT THE END OF THE DAY. THE DONOR DID NOT HAVE ANY ADVERSE EVENTS AND WAS RELEASED TO HOME POST DONATION. THE PATIENT OUTCOME WAS LISTED AS STABLE AND HEALTHY FULL PATIENT ID: (B)(6) THE COLLECTION SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102400 ↗
• MalfunctionOct 19, 2022Adverse 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 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 15631870 ↗
• InjuryAug 25, 2022Inadequacy of Device Shape and/or Size; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information; Incomplete or Inadequate Connection; Inadequacy of Device Shape and/or Size; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information; Incomplete or Inadequate Connection

  THE CUSTOMER REPORTED AN INCIDENT WHERE THE OPERATOR HAD A BLOOD EXPOSURE FROM A NEEDLE STICK FROM THE SAMPLING NEEDLE ON THE SAMPLE POUCH AFTER COLLECTING DONOR TEST SAMPLES. DURING THE PROCEDURE THE TECHNICIAN WAS ACCESSING THE ADAPTER FOR THE TUBE COLLECTION POUCH TO FILL TEST TUBES. THE CUSTOMER HAS REPORTED THAT THE ADAPTER WOULD NOT SCREW TIGHTLY OVER THE NEEDLE, AND HAD COME LOOSE IN THE TECHNICIAN HAND. THE TECHNICIAN HAD BEEN ADVISED TO CHECK THE SAMPLING NEEDLE TO MAKE SURE THAT IT IS SECURE. THE DEVICE CAME LOOSE WHILE THE TECHNICIAN WAS INSERTING/REMOVING THE TUBE FROM THE DEVICE. THE TECHNICIAN'S MIDDLE (SECOND) FINGER ON HER RIGHT HAND WAS PUNCTURED. THIS RESULTED IN A BLOOD EXPOSURE SINCE THE DONOR'S BLOOD HAD BEEN DRAWN THROUGH THE NEEDLE TO FILL THE TUBES PRIOR TO THE INCIDENT. THE TECHNICIAN WIPED THE GLOVED HAND WITH WIPES, WASHED THE AREA FULLY; FILLED OUT PROPER PAPER WORK AND WAS SENT TO CONCENTRA URGENT CARE PER THEIR SOP AND RISK MANAGEMENT REQUIREMENTS. SHE HAD TUBES DRAWN FOR SEROLOGY AND WAS GIVEN A TETANUS SHOT AS A PRECAUTION. THE CUSTOMER DECLINED TO PROVIDE PATIENT IDENTIFIER. THE PRODUCT WAS NOT RETURNED BY THE CUSTOMER FOR EVALUATION.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 15294933 ↗
• MalfunctionJul 28, 2022No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event

  THE CUSTOMER REPORTED POSSIBLE HEMOLYSIS IN THE PLATELET LINE 43 MINUTES INTO A DONATION. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. FULL DONOR ID: (B)(6).

  Patient problems: Hemolysis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15125441 ↗
• MalfunctionJun 21, 2022Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THEY STOPPED THE PLATELET COLLECTION PROCEDURE WHEN THEY SAW WHAT APPEARED TO BE HEMOLYSIS. PER THE CUSTOMER, THE PRODUCT COLLECTED WAS EXTREMELY LIPEMIC. THE CUSTOMERS LAB INDICATED THE PRESENCE OF HEMOLYSIS. THE PATIENT IS STABLE AND NO MEDICAL INTERVENTION WAS REQUIRED. FULL ID# (B)(6) THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14755278 ↗
• MalfunctionFeb 18, 2022Contamination of Device Ingredient or Reagent; 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 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. DONOR UNIT #: (B)(6) THE PLATELET COLLECTION IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559813 ↗
• MalfunctionNov 23, 2021Contamination of Device Ingredient or Reagent; 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 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. DONOR UNIT #:(B)(6), THE PLATELET COLLECTION IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863460 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE DONOR WAS DONATING PLATELETS AND PLASMA ON A TRIMA DEVICE. THE COLLECTION WAS TARGETING A DOUBLE PLATELET UNIT DONATION AND THE DONOR REQUESTED THAT THE DONATION BE STOPPED ABOUT 10 MINUTES EARLY BECAUSE SHE WAS NOT FEELING WELL. AFTER THE PROCEDURE, IT WAS REPORTED THAT THE DONOR HAD DIARRHEA AND WAS PICKED UP FROM THE DONATION SITE AS SHE DIDN'T FEEL UP TO DRIVING HERSELF HOME. THE CUSTOMER REPORTED THAT THE FOLLOWING DAY THE DONOR WAS TAKEN TO THE EMERGENCY ROOM BECAUSE SHE WAS PASSING BLOOD. THE DONOR WAS DIAGNOSED (CAT SCAN WITH CONTRAST AGENT) WITH ISCHEMIC COLITIS OF HER DESCENDING COLON, POSSIBLY DUE TO HER NORMALLY LOWER BLOOD PRESSURE AND THE BLOOD VOLUME LOST DURING THE DONATION. PRIOR TO THE PROCEDURE HER HEIGHT IS 5 FEET 7 INCHES AND WEIGHT WAS 174 LB AND HER BLOOD PRESSURE WAS MEASURED AT 114/67. THEY REMOVED 482 ML OF PLATELET AND 200 ML OF PLASMA. THE DONOR REPORTED MILD SYMPTOMS OF THE ACD-A, CONTROLLED BY ORAL TUMS. PER THE CUSTOMER, SHE IS RECOVERING AND THE DOCTOR THINKS WILL LIKELY BE WELL IN ANOTHER DAY OR SO. PER FOLLOW UP FROM THE CUSTOMER, THE PATIENT MADE A FULL RECOVERY. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE

  Patient problems: Local Reaction

  MAUDE report 12513686 ↗
• MalfunctionSep 17, 2021High Test Results; 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 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 12488763 ↗
• MalfunctionMay 11, 2020Adverse Event Without Identified Device or Use Problem; High Readings; 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 BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(6). THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10043290 ↗