CA-HP
Received Jun 22, 2011 · Event occurred Dec 10, 2008
Report 1423500-2011-08000 · MDR key 2136793
Device
Generic name
Hemodialyzer, Re-use, High Flux
Manufacturer
Nipro Corporation *usd*Catalog number
5M2733
Lot number
08A07B
Product problems
- Leak/Splash
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
A CUSTOMER REPORTED TO BAXTER (B)(4) THAT A REUSED CAHP130 DIALYZER WAS COMPLAINED BY THE HOSPITAL THAT ONLY REUSED 2 TIMES, THE LEAK OCCURRED. IT WAS LESS THAN THE USING TIMES EXPECTATION OF THE CUSTOMER.
Additional Manufacturer Narrative
(B)(4). THE SAMPLE WAS RECEIVED AND EVALUATED. UPON VISUAL INSPECTION, NO OBVIOUS DEFECTS WERE FOUND. THEN PERFORMED MANUAL LEAK TEST AND OBSERVED PRESSURE DECAY OF GREATER THAN 10 MMHG PER 60 SECONDS. FURTHER TESTING WAS DONE WITH MANUAL BUBBLE POINT TEST PER SAME SOP. PRESSURE DROPPED TO ZERO AND BUBBLES WERE SIGHTED AT THE VENOUS HEADER AND COMING OUT OF THE DIALYSATE PORT. THIS CONFIRMS THE COMPLAINT. THIS MDR IS BEING SUBMITTED AS PART OF BAXTER RENAL'S RETROSPECTIVE REVIEW & REMEDIATION PROJECT. THIS REPORT IS BEING FILED LATE TO FULFILL BAXTER'S COMMITMENT TO PERFORM A TWO YEAR RETROSPECTIVE REVIEW OF RENAL COMPLAINTS IN RESPONSE TO FDA-WARNING LETTER CHI-07-10.