Trima Accel® 82446Recalls & reported problems
Terumo Bct, Inc. · Disposable Tubing Sets, Trima Accel® LRS Platelet + Sampler, Plasma, RBC Set · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Terumo Trima Accel tubing set is a disposable set used in automated blood cell separation. Many of its 300 reports contain little detail, and the recent ones describe platelet products with higher than expected white blood cell counts. The reports include 1 death and 11 injuries. Reports fell from 51 in the 12 months before to 18 in the latest 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 300
- Deaths reported
- 1
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 300 adverse event reports that list this exact device (DI 05020583824461), received between Oct 25, 2019 and Feb 26, 2026 — classified as 1 death, 11 injuries, 288 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (154 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem282
- Insufficient Device Problem Information154
- High Test Results46
- High Readings34
- Contamination of Device Ingredient or Reagent12
- Incorrect, Inadequate or Imprecise Result or Readings8
- No Apparent Adverse Event7
- Use of Device Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions265
- No Patient Involvement28
- Insufficient Information6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Hypersensitivity/Allergic reaction3
- Local Reaction3
- Chills2
- Loss of consciousness2
Recent adverse event reports
The 25 most recent of 300 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Adverse 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 24457656 ↗MalfunctionFeb 26, 2026Adverse 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 24457503 ↗MalfunctionFeb 17, 2026Adverse 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 24367410 ↗MalfunctionJan 29, 2026Adverse 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 24211086 ↗MalfunctionJan 27, 2026Adverse 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. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE UNIT PROCESSING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR ID: (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 24190610 ↗MalfunctionJan 20, 2026Adverse 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. 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 24119135 ↗MalfunctionJan 13, 2026Adverse 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 24054603 ↗MalfunctionJan 12, 2026Adverse 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 24039918 ↗MalfunctionJan 2, 2026Adverse 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 ID: (B)(6) NO PATIENT (DONOR) WAS CONNECTED AT THE TIME OF THE EVENT; THEREFORE, NO PATIENT INFORMATION IS AVAILABLE. 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 23946228 ↗MalfunctionDec 29, 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 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 23908526 ↗MalfunctionDec 26, 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 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 UNIT PROCESSING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT ID: (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 23896620 ↗InjuryDec 18, 2025Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem
THE CUSTOMER CALLED TO REQUEST SERVICE FOR THE HEAT SEALER ON THE TRIMA DEVICE AS THE SEALER WAS MELTING THE TUBING. THE SEALER CAUSED A BLOOD LEAK ON THE PLATELET BAG TUBING, RESULTING IN A BLOOD EXPOSURE. THE OPERATOR WAS SPRAYED ON THE MOUTH WITH THE DONOR'S BLOOD. THE EXPOSED PERSON WAS SENT TO THE EMERGENCY ROOM FOR ROUTINE TESTING AND TREATMENT. PER THE DONATION CENTER, THE DONORS BLOOD WILL BE TESTED PER PROTOCOL. THE TECHNICIAN AGE, GENDER, WEIGHT AND OUTCOME ARE NOT AVAILABLE AT THIS TIME. DONOR UNIT ID: (B)(4)
Patient problems: Exposure to Body Fluids
MAUDE report 23842899 ↗MalfunctionDec 11, 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 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 23779194 ↗MalfunctionDec 4, 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 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 23717252 ↗MalfunctionDec 4, 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 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 23717052 ↗MalfunctionDec 1, 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 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 23681552 ↗MalfunctionNov 25, 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 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 23647369 ↗MalfunctionNov 25, 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 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 23647318 ↗MalfunctionOct 23, 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 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 23367848 ↗MalfunctionOct 21, 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 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 23349331 ↗MalfunctionOct 9, 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 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 23256652 ↗MalfunctionOct 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 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 23199730 ↗MalfunctionSep 16, 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 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)(4) 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 23063628 ↗MalfunctionSep 9, 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 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 #: THERE (B)(6) 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 23004820 ↗MalfunctionAug 21, 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 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)(4) 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 22865967 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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