Trima Accel® 80300Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 05020583803008), received between Jul 31, 2018 and Sep 25, 2026 — classified as 1 death, 9 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (33 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Insufficient Device Problem Information

  Customer reported that after the procedure finished the donor fainted and fell after getting off the machine to use the restroom resulting in a serious head injury. The donor was subsequently transferred to a hospital for further medical treatment. Additional follow up confirmed that medical intervention involved the use of hemostatic agents, dehydration therapy, anti-epileptic medications, and nutritional intravenous infusions. The customer declined to provide the Patient Identifier. The Collection set is not available for return because it was discarded by the customer.

  Patient problems: Syncope/Fainting

  MAUDE report 50897962 ↗
• MalfunctionFeb 3, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED AIR BUBBLES IN THE TUBING LINE DURING THE PRIME OF THE TUBING SET. THE AIR BUBBLES COULD NOT BE REMOVED. DONOR INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE PLATELET COLLECTION IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

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

  MAUDE report 24247019 ↗
• MalfunctionOct 9, 2025No 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. 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 WBC COUNT IS NOT AVAILABLE AT THIS TIME. PER THE CUSTOMER, IT WAS ONLY A USER RELATED ISSUE. 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 23256325 ↗
• MalfunctionOct 7, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  CUSTOMER REPORTED THAT DURING A DOUBLE PLATELETS COLLECTION ON A TRIMA DEVICE, THE DONOR OPENED THE SAMPLE BAG CLAMP, ON THEIR OWN, WHICH CAUSED AIR TO APPEAR IN THE DONOR LINE DURING THE RUN. THE MACHINE DISPLAYED A ONE-MINUTE PAUSE, A THREE-MINUTE PAUSE, AND A TEN-MINUTE PAUSE ALARM AT WHICH POINT THE OPERATOR DISCONNECTED THE DONOR. PATIENT IDENTIFIER UNKNOWN AT THIS TIME. PER CUSTOMER PATIENT STATUS IS "NORMAL" LUER CONNECTIONS WERE TIGHT AND THERE WAS NO CLOTTING IN THE CHANNEL OR IN THE RETURN RESERVOIR THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23235301 ↗
• MalfunctionAug 28, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  CUSTOMER REPORTED THAT THE TRIMA DEVICE ALARMED "CENTRIFUGE PRESSURE HIGH" DURING THE RUN. THEY CHECKED AND FOUND THAT THERE WAS ONGOING BUBBLE GENERATION AT ANTICOAGULANT (AC)/DRAW/RETURN MANIFOLD. PATIENT IDENTIFIER AND AGE ARE UNKNOWN AT THIS TIME. PER CUSTOMER PATIENT STATUS IS "GOOD" LUER CONNECTIONS WERE TIGHT AND THERE WAS NO CLOTTING IN THE CHANNEL OR IN THE RETURN RESERVOIR. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Air Embolism; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913304 ↗
• MalfunctionAug 14, 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 THEY FOUND AIR IN THE RETURN LINE WHEN THE PROCEDURE RAN FOR ABOUT FIVE MINUTES. PER THE CUSTOMER THE PATIENT IS "HEALTHY" AND NO MEDICAL INTERVENTION PATIENT ID AND AGE ARE UNKNOWN AT THIS TIME. LUER CONNECTIONS WERE TIGHT AND THERE WAS NO CLOTTING OBSERVED IN THE CHANNEL OR IN THE RETURN RESERVOIR, BUT ACCORDING TO THE NURSE'S OBSERVATION SHE FELT THERE WAS A CLOT INSIDE, BUT IT COULDN'T BE SEEN FROM THE PHOTO. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804875 ↗
• MalfunctionAug 5, 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 THE OPERATOR FOUND AIR BUBBLES IN THE RETURN LINE DURING THE RUN. LUER CONNECTIONS WERE TIGHT AND THERE WAS NO CLOTTING IN THE CHANNEL OR IN THE RETURN RESERVOIR. PER CUSTOMER PATIENT STATUS IS "NOTHING UNUSUAL" AND NO MEDICAL INTERVENTION WAS REQUIRED. PATIENT ID IS UNKNOWN AT THIS TIME THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715946 ↗
• MalfunctionAug 5, 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 THE MACHINE ALARMED FOR A LEVEL SENSOR FAILURE - RETURN CYCLE TOOK TOO LONG TO EMPTY THE RESERVOIR AND THERE WAS AIR BUBBLES FOUND IN THE RETURN TUBE, THE COLLECTION TUBE, AND THE AC TUBE. LUER CONNECTIONS WERE TIGHT AND THERE WAS NO CLOTTING IN THE CHANNEL, BUT CLOTTING IN THE RETURN RESERVOIR. PATIENT INFORMATION IS UNKNOWN AT THIS TIME. PER CUSTOMER PATIENT STATUS IS "GOOD CONDITION" AND NO MEDICAL INTERVENTION WAS REQUIRED. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715440 ↗
• MalfunctionMay 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 REPORTED THAT DURING A PLATELETPHERESIS PROCEDURE THE DEVICE ALARMED WITH A LEVEL SENSOR FAILURE AND THEY FOUND AIR IN THE RETURN LINE. THE PROCEDURE WAS TERMINATED BEFORE IT REACHED THE DONOR. THE CUSTOMER STATED ALL LUER CONNECTIONS WERE TIGHT AND THE BLOOD DIVERSION POUCH WAS NOT INFLATED WITH AIR. THE DONOR WAS CONNECTED BUT WAS NOT CONNECTED PRIOR TO AC PRIME. NO AIR WAS BEING DRAWN IN THROUGH THE AC LINE OR FILTER, AND THEY STATED THERE WAS NO CLOTTING IN THE CHANNEL OR RETURN RESERVOIR. THE CUSTOMER DECLINED TO PROVIDE DONOR ID. THE DONOR WAS REPORTED AS SAFE AND WAS SENT BACK AFTER OBSERVATION WITH NO ISSUES. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062615 ↗
• MalfunctionApr 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 REPORTED THAT A DONOR EXPERIENCED HEMATURIA AFTER A PROCEDURE ON A TRIMA DEVICE. PER THE CUSTOMER, WHEN THE COLLECTED YIELD WAS APPROXIMATELY 1.6*10^11, THE DEVICE ALARMED "RED BLOOD CELL (RBC) SPILLOVER" AND RED COLOR WAS SEEN IN THE TUBE ON THE RIGHT SIDE OF THE CASSETTE, AND CONTENT IN LRS CHAMBER WAS LIGHT RED AS WELL. IT WAS REPORTED THAT THE OPERATOR VERIFIED ACCORDING TO THE PROMPT AND CONTINUED THE PROCEDURE WHEN THE DEVICE ALARMED "RBC SPILLOVER" REPEATEDLY AND EVENTUALLY ENDED WITH "ALARM 96". PER THE CUSTOMER, THE OPERATOR REPLACED A NEW SET AND CONTINUED THE PROCEDURE ON THE SAME DEVICE HOWEVER, BEFORE THE FIRST RETURN CYCLE, RED COLOR WAS OBSERVED IN THE TUBE ON THE RIGHT SIDE OF THE CASSETTE AGAIN, AND THE MACHINE ALARMED "RBC SPILLOVER" AND "ALARM 96". IT WAS REPORTED THAT THE OPERATOR OBSERVED LIGHT RED CONTENT IN THE LRS CHAMBER AS WELL. THE DONOR SUBSEQUENTLY LEFT THE BLOOD CENTER, AND IT WAS NOTED THAT APPROXIMATELY ONE AND HALF HOUR AFTER THE DONATION, THE DONOR CONTACTED "LOCAL SUPPORT" AND REPORTED THAT THEY EXPERIENCED HEMATURIA. THE CUSTOMER CONTACTED THE PATIENT IMMEDIATELY AND REQUESTED THAT THE DONOR BE SENT TO THE HOSPITAL FOR EVALUATION, AN

  Patient problems: Hematuria; Hemolysis

  MAUDE report 21809121 ↗
• MalfunctionApr 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 REPORTED A BACTERIAL CONTAMINATION IN PLATELET PRODUCT IN A DOUBLE PLATELET PRODUCT COLLECTED ON (B)(6) 2025. PER CUSTOMER, ON (B)(6) 2025 WHEN THEY INTENDED TO SEND THE PLATELETS OUT, FIBRIN PRECIPITATION WAS DETECTED AND BACTERIAL CULTURE REVEALED CITROBACTER KOSERI. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE CONTAMINATION TESTING; THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. TERUMO BCT IS AWAITING RETURN OF THE DISPOSABLE SET FOR EVALUATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21806931 ↗
• MalfunctionApr 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 REPORTED THAT A PATIENT EXPERIENCED DISCOMFORT DURING A PLATELET TRANSFUSION ON A SPECTRA OPTIA DEVICE AND THE TRANSFUSION HAD TO BE ENDED. IT WAS REPORTED THAT A BACTERIAL CULTURE REVEALED STREPTOCOCCUS AGALACTIAE IN THE TRANSFUSED PRODUCT. PATIENT IDENTIFICATION AND OUTCOME ARE UNKNOWN AT THIS TIME. TERUMO BCT IS AWAITING RETURN OF THE COLLECTION SET FOR EVALUATION.

  Patient problems: Bacterial Infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21806471 ↗
• MalfunctionFeb 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 REPORTED THAT DURING A PROCEDURE THE DEVICE ALARMED "LOW-LEVEL SENSOR FAILURE" WHEN THE DONOR WAS JUST CONNECTED AND THE PROCEDURE COULD NOT BE CONTINUED. THE OPERATOR CHECKED AND FOUND THERE WAS AIR BUBBLES IN THE RETURN LINE. PATIENT INFORMATION WAS LISTED AS NO IMPACT. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355292 ↗
• InjuryFeb 3, 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 A DONOR EXPERIENCED HEMATURIA AFTER A PROCEDURE ON A TRIMA DEVICE. PER THE CUSTOMER, WHEN THE COLLECTED YIELD WAS APPROXIMATELY 1.6*10^11, THE DEVICE ALARMED "RED BLOOD CELL (RBC) SPILLOVER" AND RED COLOR WAS SEEN IN THE TUBE ON THE RIGHT SIDE OF THE CASSETTE, AND CONTENT IN LRS CHAMBER WAS LIGHT RED AS WELL. IT WAS REPORTED THAT THE OPERATOR VERIFIED ACCORDING TO THE PROMPT AND CONTINUED THE PROCEDURE WHEN THE DEVICE ALARMED "RBC SPILLOVER" REPEATEDLY AND EVENTUALLY ENDED WITH "ALARM 96". PER THE CUSTOMER, THE OPERATOR REPLACED A NEW SET AND CONTINUED THE PROCEDURE ON THE SAME DEVICE HOWEVER, BEFORE THE FIRST RETURN CYCLE, RED COLOR WAS OBSERVED IN THE TUBE ON THE RIGHT SIDE OF THE CASSETTE AGAIN, AND THE MACHINE ALARMED "RBC SPILLOVER" AND "ALARM 96". IT WAS REPORTED THAT THE OPERATOR OBSERVED LIGHT RED CONTENT IN THE LRS CHAMBER AS WELL. THE DONOR SUBSEQUENTLY LEFT THE BLOOD CENTER, AND IT WAS NOTED THAT APPROXIMATELY ONE AND HALF HOUR AFTER THE DONATION, THE DONOR CONTACTED "LOCAL SUPPORT" AND REPORTED THAT THEY EXPERIENCED HEMATURIA. THE CUSTOMER CONTACTED THE PATIENT IMMEDIATELY AND REQUESTED THAT THE DONOR BE SENT TO THE HOSPITAL FOR EVALUATION, AN

  Patient problems: Hematuria

  MAUDE report 21294427 ↗
• MalfunctionJan 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 REPORTED THAT AN AIR BUBBLE WAS FOUND IN THE RETURN LINE. THE CUSTOMER STATED THE SECTION OF AIR WAS NOT FOUND DURING THE COLLECTION. ALL LUER CONNECTIONS WERE TIGHT AND THE BLOOD DIVERSION POUCH WAS NOT INFLATED WITH AIR. THE DONOR WAS CONNECTED BUT NOT PREMATURELY PRIOR TO AC PRIME. NO AIR WAS BEING DRAWN IN THROUGH THE AC LINE OR FILTER, AND THE CUSTOMER ALSO STATED THERE WAS NO CLOTTING IN THE CHANNEL OR THE RETURN RESERVOIR. PATIENT STATUS WAS REPORTED AS "GOOD STATE" , DID NOT HAVE DISCOMFORT AND NO MEDICAL INTERVENTION WAS REQUIRED. DONOR AGE IS NOT AVAILABLE, THE CUSTOMER DECLINED TO PROVIDE PATIENT ID. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169238 ↗
• InjuryJan 6, 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 AFTER A DOUBLE PLATELET PROCEDURE ON A TRIMA DEVICE, THE DONOR ACQUIRED A NASAL BONE FRACTURE. DURING THE DONOR'S SECOND TRIP TO THE RESTROOM, THE DONOR FELL, RESULTING IN A NASAL BONE FRACTURE. ADDITIONALLY, DUE TO WEARING NEAR-SIGHTED GLASSES, THE DONOR ALSO SUSTAINED A SCRATCH ON THE CHEEK BELOW THE EYE. MEDICAL INTERVENTION INCLUDED DEBRIDEMENT OF THE WOUND AND SUTURING WITH OVER 20 STITCHES. THE DONOR WAS DISCHARGED FROM HOSPITAL ON (B)(6)2024. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Bone Fracture(s); Fall; Laceration(s)

  MAUDE report 21079496 ↗
• InjuryDec 26, 2024Adverse 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 PROCEDURE, THE DONOR REPORTED PAIN. THE OPERATOR CHECKED THE PUNCTURE POINT BUT FOUND NOTHING ABNORMAL. APPROXIMATELY 13 MINUTES LATER THE DONOR SUDDENLY SHOUTED AND IMMEDIATELY LOST CONSCIOUSNESS. THE OPERATOR LAID THE DONOR DOWN AND ADMINISTERED EMERGENCY MEASURES SUCH AS OXYGEN INHALATION, PULSE AND BLOOD PRESSURE MONITORING, AND PRESSING THE PHILTRUM-PHILTRA, BUT THERE WAS NO IMPROVEMENT. THE DONOR WAS IN A "COMA" AND HIS HEART RATE WAS LOWER THAN NORMAL, BETWEEN 40 AND 50 BPM. THE DONOR REGAINED CONSCIOUSNESS LATER BUT WAS UNSTABLE ON HIS FEET. HOURS LATER, THE DONOR WAS SENT TO THE HOSPITAL FOR EMERGENCY TREATMENT, WHERE BIOCHEMICAL TESTS, ELECTROLYTE TESTS, AND MRI SCANS WERE CONDUCTED, BUT NO ABNORMALITIES WERE DETECTED. THE DOCTORS IN HOSPITAL INFUSED SALINE AND GLUCOSE INTO THE DONOR. ON THE NEXT DAY, THE DONOR HAD FULLY RECOVERED AND REMAINS IN GOOD HEALTH WITH NO DETECTED ILLNESSES TO THIS DAY. PRIOR TO THE PROCEDURE THE PATIENT WAS LISTED AS A LITTLE NERVOUS, BUT ALL OTHER VITALS WERE NORMAL. THE CUSTOMER NOTED THAT THERE WERE NO ISSUES OBSERVED DURING THE PROCEDURE. THE CUSTOMER DECLINED TO PROVIDE THE DONOR'S ID THE COLLECTION SET

  Patient problems: Syncope/Fainting

  MAUDE report 21019210 ↗
• MalfunctionOct 7, 2024Adverse 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 AIR BUBBLES IN THE RETURN LINES AND INDICATED THAT THE DEVICE ALARMED. THE CUSTOMER DECLINE TO PROVIDE PATIENT INFORMATION AND OUTCOME. PATIENT¿S GENDER AND WEIGHT WERE OBTAINED FROM THE RUN DATA FILE (RDF). THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Air Embolism; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20386009 ↗
• MalfunctionOct 3, 2024Adverse 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 PROCEDURE ON A TRIMA DEVICE, THE DEVICE ALARMED "LEVEL SENSOR FAILURE" AND AIR BUBBLES WERE OBSERVED IN THE RETURN LINE. THE CUSTOMER DECLINED TO PROVIDE ID AND AGE, THE GENDER AND WEIGHT WERE OBTAINED FROM THE RUN DATA FILE (RDF). THE DONOR WAS REPORTED AS "FINE". 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 20362780 ↗
• MalfunctionMar 23, 2024Adverse 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 AFTER COMPLETING AN APHERESIS PLATELET PROCEDURE ON A TRIMA DEVICE, THE OPERATOR NOTICED THAT THE COLLECTED PLATELET PRODUCT LOOKED RED. THE OPERATOR TESTED THE PRODUCT AND FOUND THAT THE FREE HEMOGLOBIN CONTENT WAS HIGH. 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. 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 18965374 ↗
• MalfunctionMar 23, 2024Adverse 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 AFTER COMPLETING AN APHERESIS PLATELET PROCEDURE ON A TRIMA DEVICE, THE OPERATOR NOTICED THAT THE COLLECTED PLATELET PRODUCT LOOKED RED. THE OPERATOR TESTED THE PRODUCT AND FOUND THAT THE FREE HEMOGLOBIN CONTENT WAS HIGH. 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. THE CUSTOMER DECLINED TO PROVIDE FURTHER PATENT OR PROCEDURAL DETAILS SUCH AS HEMOLYSIS TESTING (PLASMA HEMOGLOBIN AND/OR PERCENT HEMOLYSIS). 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 18965358 ↗
• MalfunctionMar 23, 2024Adverse 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 AFTER COMPLETING AN APHERESIS PLATELET PROCEDURE ON A TRIMA DEVICE, THE OPERATOR NOTICED THAT THE COLLECTED PLATELET PRODUCT LOOKED RED. THE OPERATOR TESTED THE PRODUCT AND FOUND THAT THE FREE HEMOGLOBIN CONTENT WAS HIGH. 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. 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 18965272 ↗
• MalfunctionMar 23, 2024Adverse 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 AFTER COMPLETING AN APHERESIS PLATELET PROCEDURE ON A TRIMA DEVICE, THE OPERATOR NOTICED THAT THE COLLECTED PLATELET PRODUCT LOOKED RED. THE OPERATOR TESTED THE PRODUCT AND FOUND THAT THE FREE HEMOGLOBIN CONTENT WAS HIGH. 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. THE CUSTOMER DECLINED TO PROVIDE FURTHER PATENT OR PROCEDURAL DETAILS SUCH AS HEMOLYSIS TESTING (PLASMA HEMOGLOBIN AND/OR PERCENT HEMOLYSIS). 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 18965206 ↗
• MalfunctionMar 22, 2024Adverse 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 AFTER COMPLETING AN APHERESIS PLATELET PROCEDURE ON A TRIMA DEVICE, THE OPERATOR NOTICED THAT THE COLLECTED PLATELET PRODUCT LOOKED RED. THE OPERATOR TESTED THE PRODUCT AND FOUND THAT THE FREE HEMOGLOBIN CONTENT WAS HIGH. 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. 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 18965016 ↗
• MalfunctionMar 22, 2024Adverse 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 AFTER COMPLETING AN APHERESIS PLATELET PROCEDURE ON A TRIMA DEVICE, THE OPERATOR NOTICED THAT THE COLLECTED PLATELET PRODUCT LOOKED RED. THE OPERATOR TESTED THE PRODUCT AND FOUND THAT THE FREE HEMOGLOBIN CONTENT WAS HIGH. 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. 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 18964780 ↗