TRIMA ACCEL
Received Jul 10, 2026 · Event occurred Jun 4, 2026
Report 1722028-2026-00094 · MDR key 25782472
Device
Generic name
Trimalrs Platelet Plasma Rbc Autopas Set
Manufacturer
Terumo BctCatalog number
5824102
Lot number
2512274151
Product problems
- Insufficient Device Problem Information
Patient
NA · Male
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS LOT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.
Description of Event or Problem
CUSTOMER REPORTED THAT THEY PERFORMED A BACTERIAL CULTURE ON A PLATELET APHERESIS COLLECTION BAG AND THE SAMPLE WAS POSITIVE TO SERRATIA. THEY ALSO MADE A BACTERIAL CULTURE OF THE ACD-A SOLUTION AND PAS WHICH WERE NEGATIVE. THE PRODUCT WASN'T TRANSFUSED AND IT WAS DISCARDED. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. PER CUSTOMER PATIENT OUTCOME "HE IS OK" THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.