DeathLIF
*
Received Aug 3, 2007
Report 1221361-2007-00058 · MDR key 896783
Product problems
- Device Expiration Issue
- Use of Device Problem
- Unknown (for use when the device problem is not known)
Patient
*
- Anemia
Narrative
Additional Manufacturer Narrative
IT IS THE OPINION OF FMC NA THAT THE POSSIBLE INCORRECT USE OF THE PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO THESE EVENTS. ALSO OF NOTE IS THAT THE PRODUCT HAD EXCEEDED THE EXPIRATION DATE WHEN USED BY FACILITY. DEVICE HISTORY RECORD REVIEW: IT HAS BEEN VERIFIED THAT PURISTERIL LOT# 100611 HAD MET ALL SPECIFICATIONS PRIOR TO ITS RELEASE.
Description of Event or Problem
IT HAS BEEN CLARIFIED BY THE REPORTER OF THE EVENT THAT 17 OF THE 41 PTS DIALYZED AT THIS UNIT IN 2007 EXPERIENCED A DROP IN HEMOGLOBIN, POSSIBLY RELATED TO THE USE OF THIS PRODUCT.