MalfunctionGKT
TRIMA ACCEL
Received Aug 28, 2018 · Event occurred Aug 11, 2018
Report 7822117 · MDR key 7822117
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Product problems
- Insufficient Device Problem Information
Patient
21900 DA
- Test Result
- Test Result
Narrative
Description of Event or Problem
THE PATIENT HAS HAD SERIAL PLATELET DONATIONS OVER A LONG PERIOD, APPROXIMATELY 20 COLLECTIONS THIS YEAR ALONE. THE PATIENT WAS FOUND TO HAVE REDUCED CD4 COUNTS. THE HEMATOLOGIST FOLLOWING THE PATIENT IS SUSPICIOUS THAT THE REDUCTION IN COUNTS MAY BE RELATED TO THE APHERESIS DEVICES USED DURING PLATELET COLLECTION TO YIELD LEUKOREDUCED PLATELET UNITS.