inforMED
MalfunctionMSF

CT

Received Jun 22, 2011 · Event occurred Jan 9, 2009

Report 1423500-2011-08186 · MDR key 2137126

Device

Generic name

Hemodialyzer, Re-use, High Flux

Catalog number

5M1546

Lot number

08C10EX

Product problems

  • Fluid/Blood Leak

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

THIS COMPLAINT ORIGINATED AS A RESULT OF THE REUSE TECHNICIAN, CALLING BAXTER TO REPORT A BLOOD LEAK. THE LEAK WAS AT THE BEGINNING OF TREATMENT. THE PATIENT CONTINUED THERAPY WITH A DIFFERENT DIALYZER, THE PATIENT WENT BACK ON WITH A BACKUP (B)(4) DIALYZER AND WAS OKAY. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION REPORTED, THE PATIENT IS DOING FINE.