inforMED
MalfunctionFKH

MESA LABORATORIES 7.0 PH SOLUTION

Received Oct 2, 2013 · Event occurred Sep 20, 2013

Report 3410542 · MDR key 3410542

Device

Generic name

Ph Meter Calibration Solution

Catalog number

02.0031 AND 02.0032

Lot number

ML-P7-1148

Product problems

  • Calibration Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

REC'D NOTIFICATION OF POSSIBLE CONTAMINATION OF MESA LABORATORIES 7.0 PH SOLUTION ON (B)(6) /2013. ALL INVENTORY OF THIS SOLUTION WAS REMOVED BY CLINIC MGR FROM CLINICAL AREA AND USE OF PH STRIPS WAS INSTITUTED TO CHECK PH OF DIALYSATE IN DIALYSIS MACHINES UNTIL FURTHER RESOLUTION TO THIS ISSUE.