TRIMA ACCEL SYSTEM
Received Jun 5, 2017 · Event occurred May 3, 2017
Report MW5070244 · MDR key 6621499
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct Inc.Product problems
- Computer Software Problem
Patient
63 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2017, THE TERUMO BCT TRIMA ACCEL SYSTEM (DEVICE SN (B)(4)) ALLOWED AN APHERESIS OPERATOR TO COLLECT A 2RBC (DOUBLE RBC) PRODUCT (BAG 1 WAS 326ML AND BAG 2 WAS 432ML) AND A 264ML PLASMA, THIS PROCEDURE IS NOT ONE THAT IS ON OUR PROCEDURE LIST AND IS NOT ONE THAT WOULD EVER BE ELECTED TO PERFORM. ALTHOUGH THE OPERATOR INITIALLY SELECTED A PLASMA PROCEDURE, 19 MINUTES INTO THE PROCEDURE, THE DEVICE ALLOWED THE OPERATOR TO CHANGE THE PROCEDURE TO A 2RBC WITH SINGLE PLASMA. FOLLOWING THE COLLECTION, THE OPERATOR REPORTED WHAT HAPPENED TO HIS MANAGER AND THE QUALITY DEPARTMENT AND AN INVESTIGATION BEGAN. A ROOT CAUSE ANALYSIS EVENT WAS HELD ON (B)(6) 2017 INTERNALLY AT INOVA BLOOD DONOR SERVICES REGARDING THE PROCEDURE AND THE INCIDENT WAS REPORTED TO TERUMO FOR FURTHER INVESTIGATION. TERUMO'S REPORT TOOK SEVERAL DAYS AND THEIR FINAL STANCE ON THE PROCEDURE WAS THAT THE "TRIMA ACCEL ACTED AS INTENDED" AND THEIR ORGANIZATION HAD OBSERVED ISSUES SIMILAR TO THIS IN THE PAST BUT DIDN'T FEEL THERE WAS A NEED TO NOTIFY ANY CUSTOMERS OR CHANGE ANY OF THEIR BUSINESS PRACTICES.