CT
Received Jun 22, 2011 · Event occurred Mar 26, 2010
Report 1423500-2011-08098 · MDR key 2136507
Device
Generic name
Hemodialyzer, Re-use, High Flux
Manufacturer
Nipro Corporation *usd*Catalog number
5M1546
Lot number
09I07DX
Product problems
- Material Discolored
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4).THE SAMPLE WAS RECEIVED AND EVALUATED. THE DIALYZER WAS VISUALLY INSPECTED BY THE HEMOLAB AND NO DISCOLORATION WAS NOTED. THEREFORE, THIS COMPLAINT COULD NOT BE VERIFIED.
Description of Event or Problem
A DIALYSIS TECHNICIAN REPORTED TO BAXTER A DIALYZER THAT TURNED GREY IN COLOR. A FOLLOW UP WAS DONE VIA PHONE. THE ADMINISTRATOR STATED THAT WHEN THE BLOOD HIT THE DIALYZER, THAT IS WHEN IT TURNED GREY IN COLOR, AT THE VERY BEGINNING OF THE SETUP. THERE WAS NO MEDICAL INTERVENTION OR HOSPITALIZATION AS A RESULT OF THIS INCIDENT. THE PATIENT RESUMED THERAPY WITH A NEW DIALYZER AND WAS OKAY.