TRIMA ACCEL
Report
- Report Number
- 1722028-2025-00083
- Event Type
- Malfunction
- Date Received
- April 8, 2025
- Date of Event
- January 7, 2025
- Report Date
- April 8, 2025
- Manufacturer
- TERUMO BCT
- Product Code
- GKT
- PMA / PMN Number
- BK190332
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN D.4, H.6 AND H.11. INVESTIGATION: A USED TRIMA ACCEL SET, CONTAINING BLOOD THROUGHOUT, WAS RECEIVED. THE PLATELET AND PLASMA BAGS WERE NOT RETURNED, BUT RED CELLS WERE OBSERVED IN THE PLATELET BAG LINE TUBING. THE MINI PITCH CLAMPS WERE ASSEMBLED CORRECTLY, AND THE CLAMPS WERE ON THE CORRECT LINES. HOWEVER, THE MINI PINCH CLAMP ON THE PLATELET LINE WAS FOUND TO BE ASKEW AND NOT FULLY OCCLUDING THE TUBING. PAS FLUID WAS OBSERVED IN THE PAS LINE, INDICATING THE CUSTOMERS TRIED TO ADD PAS. THERE WAS NO CLUMPING OR CLOTTING OBSERVED. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THIS LOT. THERE WERE NO EVENTS NOTED IN THE DHR THAT WOULD HAVE CONTRIBUTED TO THE ELEVATED WBC COUNT EXPERIENCED BY THE CUSTOMER. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.
INVESTIGATION: A USED TRIMA ACCEL SET, CONTAINING BLOOD THROUGHOUT, WAS RECEIVED. THE PLATELET AND PLASMA BAGS WERE NOT RETURNED, BUT RED CELLS WERE OBSERVED IN THE PLATELET BAG LINE TUBING. THE MINI PITCH CLAMPS WERE ASSEMBLED CORRECTLY, AND THE CLAMPS WERE ON THE CORRECT LINES. HOWEVER, THE MINI PINCH CLAMP ON THE PLATELET LINE WAS FOUND TO BE ASKEW AND NOT FULLY OCCLUDING THE TUBING. PAS FLUID WAS OBSERVED IN THE PAS LINE, INDICATING THE CUSTOMERS TRIED TO ADD PAS. THERE WAS NO CLUMPING OR CLOTTING OBSERVED. INVESTIGATION IS IN PROCESS; A FOLLOW-UP REPORT WILL BE PROVIDED.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B.5, H.6 AND H.11. INVESTIGATION: A USED TRIMA ACCEL SET, CONTAINING BLOOD THROUGHOUT, WAS RECEIVED. THE PLATELET AND PLASMA BAGS WERE NOT RETURNED, BUT RED CELLS WERE OBSERVED IN THE PLATELET BAG LINE TUBING. THE MINI PITCH CLAMPS WERE ASSEMBLED CORRECTLY, AND THE CLAMPS WERE ON THE CORRECT LINES. HOWEVER, THE MINI PINCH CLAMP ON THE PLATELET LINE WAS FOUND TO BE ASKEW AND NOT FULLY OCCLUDING THE TUBING. PAS FLUID WAS OBSERVED IN THE PAS LINE, INDICATING THE CUSTOMERS TRIED TO ADD PAS. THERE WAS NO CLUMPING OR CLOTTING OBSERVED. THE TRIMA ACCEL DEVICE HAS SOFTWARE ALGORITHMS IN PLACE THAT USE THE RBC DETECTOR OUTPUT TO MONITOR AND FLAG IF RBC CONTAMINATION OCCURS DURING PAS ADDITION. IT IS IMPORTANT FOR OPERATORS TO VERIFY PROPER CLOSURE OF THE CHANNEL LINE CLAMPS. IF THESE CLAMPS ARE NOT FULLY OCCLUDING THE CHANNEL LINES, FLUID FROM THE CHANNEL CONTAINING RBCS AND/OR WBCS IS PULLED UP AND CAN ENTER THE PLATELET PRODUCT BAGS, RESULTING IN THE PLATELET PRODUCT BEING FLAGGED FOR WBC CONTENT VERIFICATION. DESPITE MULTIPLE FOLLOW-UP ATTEMPTS, THE CUSTOMER DID NOT PROVIDE THE DEVICE SERIAL NUMBER OR THE HIGH PRIORITY QUESTIONNAIRE, THEREFORE IT WAS NOT POSSIBLE TO CONFIRM IF THE DEVICE PROVIDED A VERIFY WBC MESSAGE AT THE END OF THE PROCEDURE. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THIS LOT. THERE WERE NO EVENTS NOTED IN THE DHR THAT WOULD HAVE CONTRIBUTED TO THE ELEVATED WBC COUNT EXPERIENCED BY THE CUSTOMER. A DISPOSABLE COMPLAINT HISTORY SEARCH WAS PERFORMED FOR THIS LOT AND FOUND NO OTHER REPORTS FOR SIMILAR ISSUES ON THIS LOT. THE CUSTOMER HISTORY REPORT INDICATES NO FURTHER RELATED ISSUES HAVE BEEN REPORTED FOR THIS CUSTOMER. ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THIS COMPLAINT. BASED ON THE RETURNED PART INVESTIGATION, THE ROOT CAUSE FOR THE RBC SPILLOVER WAS DETERMINED TO BE INCOMPLETE CLOSURE OF THE PLATELET CHANNEL LINE CLAMP, RESULTING IN FLUID FROM THE CHANNEL (CONTAINING RBCS AND/OR WBCS) ENTERING THE PLATELET PRODUCT DURING PAS ADDITION.
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. IT WAS REPORTED THAT THE PRESERVATION SOLUTION WAS SET UP ACCORDING TO THE INSTRUCTIONS AND THEY RECEIVED A MESSAGE INDICATING THAT THE PRESERVATION SOLUTION WAS NOT FLOWING. THEY CHECKED THE LINES AND THE PRODUCT TO VERIFY THAT THE LINES WERE CLAMPED. ONCE THE CHECK WAS COMPLETE, THE PROCEDURE WAS TO VALIDATED TO CONTINUE. ONCE THIS STEP WAS VALIDATED, SOME BLOOD FLEW TO THE PLATELET LINE, AND THE PROCEDURE WAS STOPPED. 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. DONATION ID: (B)(4) WBC COUNT IS UNKNOWN AT THIS TIME. THIS PRODUCT IS NOT AVAILABLE WITHIN THE US, BUT THIS REPORT IS BEING FILED DUE TO AN ALLEGED FAILURE THAT COULD OCCUR ON A SIMILARLY MARKETED DEVICE PLATFORM CLEARED FOR USE BY THE FDA.
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. IT WAS REPORTED THAT THE PRESERVATION SOLUTION WAS SET UP ACCORDING TO THE INSTRUCTIONS AND THEY RECEIVED A MESSAGE INDICATING THAT THE PRESERVATION SOLUTION WAS NOT FLOWING. THEY CHECKED THE LINES AND THE PRODUCT TO VERIFY THAT THE LINES WERE CLAMPED. ONCE THE CHECK WAS COMPLETE, THE PROCEDURE WAS TO BE VALIDATED TO CONTINUE. ONCE THIS STEP WAS VALIDATED, SOME BLOOD FLEW TO THE PLATELET LINE, AND THE PROCEDURE WAS STOPPED. 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. DONATION ID: (B)(6). WBC COUNT IS UNKNOWN AT THIS TIME. THIS PRODUCT IS NOT AVAILABLE WITHIN THE US, BUT THIS REPORT IS BEING FILED DUE TO AN ALLEGED FAILURE THAT COULD OCCUR ON A SIMILARLY MARKETED DEVICE PLATFORM CLEARED FOR USE BY THE FDA.
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. IT WAS REPORTED THAT THE PRESERVATION SOLUTION WAS SET UP ACCORDING TO THE INSTRUCTIONS AND THEY RECEIVED A MESSAGE INDICATING THAT THE PRESERVATION SOLUTION WAS NOT FLOWING. THEY CHECKED THE LINES AND THE PRODUCT TO VERIFY THAT THE LINES WERE CLAMPED. ONCE THE CHECK WAS COMPLETE, THE PROCEDURE WAS TO VALIDATED TO CONTINUE. ONCE THIS STEP WAS VALIDATED, SOME BLOOD FLEW TO THE PLATELET LINE, AND THE PROCEDURE WAS STOPPED. 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. DONATION ID: (B)(6) WBC COUNT IS NOT AVAILABLE FOR THIS EVENT. DESPITE MULTIPLE FOLLOW-UP ATTEMPTS NO FURTHER PROCEDURAL DETAILS WERE PROVIDED. THIS PRODUCT IS NOT AVAILABLE WITHIN THE US, BUT THIS REPORT IS BEING FILED DUE TO AN ALLEGED FAILURE THAT COULD OCCUR ON A SIMILARLY MARKETED DEVICE PLATFORM CLEARED FOR USE BY THE FDA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 707580 | TRIMA ACCEL | TRIMA LRS PLT W/FILTER+SAMPLER+AUTOPAS | GKT | TERUMO BCT | 2407162142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |