CT
Received Jun 29, 2011 · Event occurred Mar 22, 2010
Report 1423500-2011-08465 · MDR key 2143322
Device
Generic name
Hemodialyzer, Re-use, High Flux
Manufacturer
Nipro Corporation *usd*Catalog number
5M1546
Lot number
09I07DX
Product problems
- Fluid/Blood Leak
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
A DIALYSIS TECHNICIAN REPORTED TO BAXTER THAT THERE WAS A BLOOD LEAK IN A DIALYZER. A FOLLOW UP WAS DONE VIA PHONE. THE ASSISTANT ADMINISTRATOR STATED, THE BLOOD LEAK WAS FROM THE HEADER OF THE DIALYZER AT THE VENOUS END. THE BLOOD LEAK OCCURRED DURING THE EARLY MIDDLE PART OF THE TREATMENT. IT WAS DISCOVERED BY A BLOOD LEAK ALARM ON THE MACHINE. IT WAS CONFIRMED TWICE BY A HEMASTIX TEST. THE ESTIMATED BLOOD LOSS TO THE PATIENT WAS 150 TO 250 MLS. THERE WAS NO MEDICAL INTERVENTION OR HOSPITALIZATION AS A RESULT OF THIS INCIDENT. THE PATIENT RESUMED THERAPY WITH A NEW DIALYZER AND WAS OKAY.
Additional Manufacturer Narrative
(B)(4). THE SAMPLE WAS RECEIVED AND EVALUATED. UPON VISUAL INSPECTION NO DEFECTS WERE OBSERVED. A LEAK TEST WAS PERFORMED AND BUBBLES WERE OBSERVED COMING FROM THE FIBERS AND OUT THE ARTERIAL AND VENOUS DIALYSATE PORTS. THIS CONFIRMS THE COMPLAINT. THE ROOT CAUSE WAS NOT DETERMINED. 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 (B)(4).