MCB 214-100 BICARB SYSTEM
Received Sep 5, 2015 · Event occurred Aug 7, 2015
Report 3019131-2015-00003 · MDR key 5059342
Device
Product problems
- Use of Device Problem
Patient
Not reported
- Chemical Exposure
Narrative
Additional Manufacturer Narrative
RECEIVED INITIAL REPORT FROM CLINIC ON 8.7.2015. MULTIPLE CONTACT ATTEMPTS HAVE BEEN MADE ALONG WITH MESSAGES LEFT FOR DR. (B)(6) OVER THE LAST 30 DAYS REQUESTING ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN FORTHCOMING.
Description of Event or Problem
CLINIC CALLED TO REPORT THAT WHILE PERFORMING A BLEACH DISINFECT OF THEIR MCP SYSTEM (HEMODIALYSIS DIALYSATE BICARBONATE MIXER), THE STAFF INADVERTENTLY SENT THE MIXTURE TO THE PATIENT FLOOR. POTENTIAL OF AFFECTING 20 PATIENTS. CLINIC WAS MONITORING HEMO LEVELS AND DID NOT REPORT ANY ADVERSE EFFECTS.