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Received Aug 3, 2007
Report 1221361-2007-00056 · MDR key 893593
Product problems
- Device Expiration Issue
- Use of Device Problem
- Unknown (for use when the device problem is not known)
Patient
55 YR
- Anemia
- Stroke/CVA
- Emotional Changes
- Neurological Deficit/Dysfunction
- Stroke
- Hospitalization required
Narrative
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. THIS PARTICULAR PT REPORTEDLY PRESENTED WITH BEHAVIORAL CHANGES AND WAS ADMITTED TO THE HOSPITAL AND WAS DIAGNOSED WITH A CVA. THIS PT HAS RECOVERED AND IS DOING WELL RECEIVING HEMODIALYSIS.
Additional Manufacturer Narrative
IT IS THE OPINION 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.