MESA LABORATORIES 7.0 PH SOLUTION
Received Oct 3, 2013 · Event occurred Sep 25, 2013
Report 3670470 · MDR key 3670470
Device
Generic name
Mesa Laboratories 7.0 Ph Solution
Manufacturer
Mesa LaboratoriesCatalog number
02.0031
Lot number
ML-P7-1148
Product problems
- Microbial Contamination of Device
- Contamination of Device Ingredient or Reagent
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A 7.0 PH SOLUTION FROM (B)(4) RECALLED. THIS SOLUTION IS USED TO CALIBRATE PHOENIX METERS WHICH ARE USED TO TEST PH AND CONDUCTIVITY ON OUR DIALYSIS MACHINES. FIRST ALERT SENT OUT FROM MESA LABORATORIES ON (B)(6) INDICATING 'BACTERIA GROWTH' IN 7.0 PH SOLUTION. ALERT INFORMS US TO SEQUESTER ALL AFFECTED BOTTLES OF 7.0 PH SOLUTIONS. SOLUTION SEQUESTERED ON (B)(6) 2013. ALL DIALYSIS MACHINES HEAT OR BLEACH DISINFECTED PER THE FIRST ALERT. SECOND ALERT SENT OUT ON (B)(6). THIS ALERT CHANGES TERMINOLOGY FROM 'BACTERIA GROWTH' TO 'MOLD.' ALERT INFORMS US TO PERFORM BLEACH DISINFECTION ON ALL DIALYSIS MACHINES. MACHINES DISINFECTED PER THE ALERT.