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Received Aug 3, 2007
Report 1221361-2007-00057 · MDR key 896761
Product problems
- Device Expiration Issue
- Use of Device Problem
- Unknown (for use when the device problem is not known)
Patient
24 YR
- Anemia
- Improved patient condition
- Dizziness
- Transfusion of blood products
- Blood pressure, low
- Hospitalization required
Narrative
Additional Manufacturer Narrative
IT IS THE OPINION OF FMC NA THAT THE POSSIBLE INCORRECT USE OF THE PRODUCT MAY HAVE CAUSED OR CONTIRBUTED TO THESE EVENTS. ALSO OF NOTE IS THAT 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 2007 EXPERIENCED A DROP IN HEMOGLOBIN, POSSIBLY RELATED TO THE USE OF THIS PRODUCT. THIS PARTICULAR PT REPORTEDLY PRESENTED WITH SYMPTOMS OF A PERSISTENT LOW BLOOD PRESSURE ALONG WITH LIGHT-HEADEDNESS AND FEELING DIZZY. THIS PT WAS ADMITTED TO THE HOSP AND RECEIVED 2 UNITS OF PRBC. THIS PT HAS RECOVERED AND IS DOING WELL RECEIVING PERITONEAL DIALYSIS.