MalfunctionLIF

MINNCARE 500ML WEEKLY

Received Aug 8, 2014 · Event occurred Jun 24, 2014

Report MW5037753 · MDR key 4024488

Device

Generic name

Wro 300 Portable Ro

Manufacturer

Gambro

Model number

WRO - W300H

Lot number

741143

Product problems

Device Operates Differently Than Expected

Patient

No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

PORTABLE RO 28948 - AFTER WEEKLY DISINFECTION WITH MINNCARE, MACHINES CONTINUE TO SHOW POSITIVE RESIDUE. AFTER RINSING FOR 24 HRS, STILL SHOWS A POSITIVE RESIDUAL. TURNED OFF AND BACK ON SHOWED A NEGATIVE RESIDUAL. TURNED OFF AND THEN BACK ON AND SHOWED A POSITIVE RESIDUAL WHEN ON MINNCARE USED ON THE RO MACHINE. THIS WAS (B)(6) 2014. ON (B)(6) 2014 MACHINE WAS SEND TO OUR BIOMED DEPT AND THE SAME PROBLEM CONTINUED. EVENT REAPPEARED AFTER REINTRODUCTION: YES.