CA-HP
Received Jun 22, 2011 · Event occurred Dec 10, 2008
Report 1423500-2011-07999 · MDR key 2136792
Device
Generic name
Hemodialyzer, Re-use, High Flux
Manufacturer
Nipro Corporation *usd*Catalog number
5M2733
Lot number
08B25B
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
A CUSTOMER REPORTED TO BAXTER (B)(4) THAT FIVE UNITS OF CAHP-130 DIALYZER WERE NOTED LEAK OR BLOOD LEAK WITH ALARM ONLY AFTER TWO OR THREE TIMES OF REPROCESSING, WHICH MUCH LESS NORMAL REUSE TIMES (NORMAL REUSE 10 TIMES).
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.