DSU-H
Received Apr 4, 2018 · Event occurred Jan 25, 2018
Report 3003337893-2018-00001 · MDR key 7397667
Device
Generic name
System, Water Purification, General Medical U, Product Code: Nhv
Manufacturer
Nephros IncModel number
70-0285Lot number
PI17/0342
Product problems
- Break
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
WHEN INITIALLY EVALUATION WITHOUT THE PRODUCT RETURN, IT WAS CONCLUDED THAT THE EVENT WAS NOT MDR REPORTABLE AND WAS LIKELY THAT NEPHROS DISINFECTION AND INSTALLATION PROCEDURES WERE NOT FOLLOWED. NONETHELESS, AFTER A COMPLETE INVESTIGATION THERE WAS INDEED FIBER BREAKS IN BOTH BUNDLES OF THE FILTER WHICH COULD ALLOW BACTERIA TO PASS THROUGH. THEREFORE, FROM THE INFORMATION GATHERED ON 03/05/2018, THIS IS AN REPORTABLE EVENT.
Description of Event or Problem
ON (B)(6) 2018 IT WAS REPORTED THAT A HEALTHCARE FACILITY RECEIVED A POSITIVE CULTURE DOWNSTREAM OF A DSU-H (70-0285) IN ONE OF THEIR ICE MACHINES.THERE WAS NO REPORTED ADVERSE EVENTS OR HEALTH ISSUES CONNECTED WITH THE POSITIVE RESULT. NEPHROS DSU-H IS AN IN-LINE WATER FILTER, CLASS II MEDICAL DEVICE THAT IS PLACED BEFORE ICE MACHINES IN HEALTH CARE FACILITIES IN ORDER TO RETAIN BACTERIA, VIRUS AND ENDOTOXIN. THE USER FACILITY ROUTINELY TEST THEIR WATER AT THEIR ICE MACHINE AND FOUND THAT THERE WAS POSITIVE BACTERIA DETECTED. FROM THE INITIAL DISCUSSION, IT IS LIKELY THAT OUR DISINFECTION AND INSTALLATION PROCEDURES WERE NOT FOLLOWED.