MalfunctionMSF
CT
Received Jun 20, 2011 · Event occurred May 3, 2010
Report 1423500-2011-07971 · MDR key 2134673
Device
Generic name
Hemodialyzer, Re-use, High Flux
Manufacturer
Nipro Corporation *usd*Catalog number
5M1546
Lot number
09H03DX
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE SAMPLE WAS RECEIVED AND EVALUATED. A VISUAL INSPECTION WAS PERFORMED ON EACH AND NO OBVIOUS DEFECTS WERE FOUND. A MANUAL BUBBLE POINT TEST WAS PERFORMED ON EACH DIALYZER AND LEAKAGE AT THE VENOUS HEADER AND BUBBLES FLOWED OUT THE DIALYSATE PORT. THIS CONFIRMS THE COMPLAINT.
Description of Event or Problem
A CUSTOMER REPORTED TO BAXTER (B)(4) THAT THE DIALYZER FAIL THE TEST. IT CAN NOT PASS DURING THE SECOND TIME REUSED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.