MalfunctionMSE
F6 DIALYZER FINISHED ASSY (CASE)
Received Sep 29, 2010 · Event occurred Aug 10, 2010
Report 1713747-2010-00036 · MDR key 1865259
Device
Product problems
- Leak/Splash
Patient
NA
- Blood Loss
Narrative
Description of Event or Problem
WE HAVE RECEIVED A REPORT INDICATING THAT A HOME HEMODIALYSIS PT HAD "BLOOD LEAK" DURING TREATMENT. IT WAS VERIFIED BY THE PT'S MOTHER THAT THERE WAS AN INTERNAL BLOOD LEAK THAT OCCURRED. AT THAT TIME, NO ADD'L INFO WAS PROVIDED ON THE EVENT. HOWEVER, AFTER SPEAKING WITH THE RN ON (B)(6) 2010 IT WAS LEARNED THAT THE PT IS A (B)(6) MEDICALLY FRAGILE PT. CURRENTLY THIS PT CONTINUES HEMODIALYSIS WITH THE USE OF THIS PRODUCT. SAMPLES ARE AVAILABLE FOR AN EVAL.
Additional Manufacturer Narrative
ADD'L INFO REGARDING THE EVENT WAS RECEIVED ON (B)(4) 2010.