Trima Accel® 80360Recalls & reported problems
Terumo Bct, Inc. · Disposable Tubing Sets, Platelet + Sampler, Plasma, Auto RBC Sets · Class 2
Quick summary
This is a disposable tubing set used with the Terumo BCT Trima Accel automated blood cell separator during blood and platelet donation. There are 24 adverse event reports naming its identifier, mostly describing collected blood products testing with elevated white blood cell content; two reports mention donor injuries such as fainting or a reaction with swelling and bruising, with no deaths. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05020583803602), received between Sep 21, 2018 and Sep 30, 2020 — classified as 2 injuries, 22 malfunctions.
The most frequently reported specific device problem is “High Readings” (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
Device problems
- Adverse Event Without Identified Device or Use Problem23
- High Readings7
- High Test Results4
- Chemical Problem1
- Human-Device Interface Problem1
- Patient-Device Incompatibility1
- Use of Device Problem1
Patient problems
- No Patient Involvement20
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient2
- Reaction2
- Loss of consciousness1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2020High 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 RED BLOOD CELL (RBC) 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 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 10607174 ↗MalfunctionSep 16, 2020Use of Device Problem; Chemical Problem; Use of Device Problem
THE DONOR ID, WEIGHT AND GENDER WERE PROVIDED BY THE CUSTOMER. THEREFORE, PATIENT ID IS NONE AND THE EIGHT AND GENDER PROVIDED IN A.3 AND A.4 IN THE INITIAL SUBMISSION ARE NOT RELATED TO THIS EVENT. THE RBC PRODUCT WAS SENT BACK WITH THE DISPOSABLE SET AND NOT TRANSFUSED. THEREFORE, THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THIS INCIDENT, THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. PER THE CUSTOMER, THIS WAS AN UNEVENTFUL COLLECTION WITH NO ALARMS AND NO CLOTTING WAS OBSERVED.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 10540836 ↗MalfunctionJun 30, 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)(4). 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 10212177 ↗MalfunctionApr 29, 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 RED BLOOD CELL (RBC) 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 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 10010010 ↗InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT DURING A DONATION PROCEDURE, A DONOR STARTED TO EXPERIENCE INTENSE LEG CRAMPS, THE EXPERIENCED A BRIEF LOSS OF CONSCIOUSNESS (ABOUT 10-20 SECONDS). THE DONOR HIT HIS HEAD ON THE DONOR BED WHEN HE PASSED OUT. THE STAFF ADMINISTERED FIRST AID AND GAVE THE DONOR FLUIDS BY MOUTH. THE DONOR WAS RELEASED FROM THE DONOR ROOM AND WENT HOME. THE NEXT DAY THE STAFF FOLLOWED UP WITH THE DONOR. HE STILL COMPLAINED OF A HEADACHE, SO THEY SUGGESTED THAT THE DONOR GO TO THE ER FOR FOLLOW UP. THE CUSTOMER STATED THAT THE DONOR WAS DIAGNOSED WITH A MILD CONCUSSION. THE DONOR WAS RELEASED FROM THE ER. THE STAFF FOLLOWED UP AFTER HIS RELEASE AND STATED HE WAS DOING OK AND NO FOLLOW UP WAS NECESSARY. DONOR IS CURRENTLY IN STABLE CONDITION. THE CUSTOMER DECLINED TO PROVIDE PATIENT (DONOR) AGE. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: Loss of consciousness; Reaction
MAUDE report 9830623 ↗MalfunctionFeb 4, 2020High Readings; 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 WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: W091019294127 THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Patient Involvement
MAUDE report 9664848 ↗MalfunctionOct 18, 2019High 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 WHITE BLOODCELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(4). THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Patient Involvement
MAUDE report 9208109 ↗InjuryJul 12, 2019Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT FOLLOWING A PLATELET COLLECTION PROCEDURE ON TRIMA, A DONOR EXPERIENCED A REACTION. THE DONOR EXPERIENCED SWELLING AROUND THE EYES AND MOUTH AND THE NEXT DAY PRESENTED BRUISING AROUND THE NEEDLE SITE EXTENDING UP TO THE DONOR'S BICEP. THE DONOR VISITED HER OWN PHYSICIAN DUE TO THE SWELLING AND WAS PRESCRIBED PREDNISONE, WHICH CAUSED THE SYMPTOMS TO SUBSIDE. AN ULTRASOUND WAS PERFORMED ON THE DONOR'S ARM, WHICH VERIFIED THERE WAS NO DEEP VEIN THROMBOSIS. PER THE CUSTOMER, THERE WERE NO PROBLEMS DURING THE DONATION AND THE DONOR REPORTED THE NEXT MORNING THAT SHE WAS FEELING MUCH BETTER. FULL DONOR ID: (B)(6). THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: Reaction
MAUDE report 8785722 ↗MalfunctionJul 5, 2019Adverse 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 Patient Involvement
MAUDE report 8764445 ↗MalfunctionJul 5, 2019Adverse 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 Patient Involvement
MAUDE report 8764328 ↗MalfunctionJul 5, 2019Adverse Event Without Identified Device or Use Problem; High Test Results; 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 Patient Involvement
MAUDE report 8764241 ↗MalfunctionJun 28, 2019Adverse 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 RED BLOOD CELL (RBC) 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. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Patient Involvement
MAUDE report 8744753 ↗MalfunctionJun 28, 2019Adverse 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 APHERESIS RED CELL (RBC) 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 THEE VENT. DONOR UNIT #: (B)(6). THE RBC COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Patient Involvement
MAUDE report 8744690 ↗MalfunctionJun 13, 2019Adverse 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 WHITE BLOOD CELL (RWBC) 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 Patient Involvement
MAUDE report 8696449 ↗MalfunctionApr 18, 2019Adverse 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 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 Patient Involvement
MAUDE report 8528203 ↗MalfunctionMar 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REQUESTED THE RUN DATA FILE BE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE HIGHER-THAN-EXPECTED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. DONOR UNIT ID: (B)(4). THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THIS INCIDENT, 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 Patient Involvement
MAUDE report 8409213 ↗MalfunctionMar 8, 2019Adverse 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 WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT#: (B)(4). THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Patient Involvement
MAUDE report 8405644 ↗MalfunctionFeb 6, 2019Adverse 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 WHITE BLOODCELL (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 Patient Involvement
MAUDE report 8312351 ↗MalfunctionJan 10, 2019High 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 WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT ID IS NOT AVAILABLE, AT THIS TIME. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Patient Involvement
MAUDE report 8238021 ↗MalfunctionOct 9, 2018Adverse 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 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 Patient Involvement
MAUDE report 7948970 ↗MalfunctionOct 8, 2018Adverse 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 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 Patient Involvement
MAUDE report 7943875 ↗MalfunctionOct 8, 2018Adverse 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 WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: . THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Patient Involvement
MAUDE report 7943797 ↗MalfunctionSep 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT DURING A TRIMA COLLECTION PROCEDURE, THEY NOTICED CLOTS IN THERE TURN RESERVOIR, AND WHEN THE OPERATOR REMOVED THE NEEDLE, THERE WAS A CLOT AT THE VENIPUNCTURE SITE. THE CLOT AT THE NEEDLE WAS DISCOVERED WHEN THEY REMOVED THE NEEDLE FROM THE DONOR'S ARM. PER THE CUSTOMER, THE DONOR WAS OK AND HEALTHY. HE HAD NO PROBLEMS DURING OR POSTPROCEDURE. THE COMPLETE PATIENT ID IS (B)(6).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7913221 ↗MalfunctionSep 21, 2018Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THE OPERATOR INADVERTENTLY ENTERED A FEMALE DONOR AS A MALE FOR ATRIMA PLATELET AND PLASMA COLLECTION PROCEDURE. THE AC INFUSION RATE WAS >1.2 MLS PER MINUTE PER LITER OF TBV. THE DONOR'S ACTUAL TBV IS 4262ML. FOR THE PROCEDURE THAT WAS COMPLETED, THE TBV WAS 4679 ML. THE MAXIMUM AC INFUSION RATE IS 1.2 MLS/MIN/LITER OF TBV. BASED ON THE ACTUAL DONOR'S TBV OF 4262 ML, SHE SHOULD ONLY HAVE RECEIVED 5.1 ML/MIN INSTEAD OF 5.85 ML/MIN. PER THE CUSTOMER, THE DONOR IS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7898400 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.