CENTRISOL ACID CONCENTRATE
Received Oct 18, 2024
Report 2150060-2024-00055 · MDR key 20480232
Device
Generic name
Centrisol Acid Concentrate
Manufacturer
Medivators Inc.Model number
SB-352Lot number
(10)591951
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
STERIS IS NOT THE MANUFACTURER OF THE CENTRISOL ACID CONCENTRATE SUBJECT OF THE REPORTED EVENT. STERIS HAS NOTIFIED THE MANUFACTURER, ROCKWELL MEDICAL, OF THE REPORTED EVENT TO INTERNALLY INVESTIGATE AND EVALUATE FOR REPORTABILITY. STERIS IS SUBMITTING THIS REPORT SOLELY IN RESPONSE TO THE RECEIVED MEDWATCH. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED VIA MEDWATCH MW5159069 THAT "CONCERN ABOUT LOOK ALIKE LABELS FOR DIALYSIS ACID SOLUTIONS FROM OUTSET MEDICAL. THE 2K AND 3K ACID BATHS HAVE THE SAME WHITE WRITING ON OTHERWISE IDENTICAL RED BACKGROUND LABELS. IT WOULD BE EASY TO MIX UP THE SOLUTIONS DURING STORAGE AND CREATE A POSSIBLE ERROR." NO REPORT OF INJURY.