MAUDE Adverse Event Report: NEPHROS INC DSU-H; SYSTEM, WATER PURIFICATION, GENERAL MEDICAL U, PRODUCT CODE: NHV

Model Number	70-0285
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
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.
Event or Problem Description
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.

• Brand Name: DSU-H
• Common Device Name: SYSTEM, WATER PURIFICATION, GENERAL MEDICAL U, PRODUCT CODE: NHV
• Manufacturer (Section D): NEPHROS INC; 380 lackawanna place; south orange NJ 07079
• MDR Report Key: 7397667
• Report Number: 3003337893-2018-00001
• Device Sequence Number: 13461622
• Product Code: NHV
• UDI-Device Identifier: 00896241002343
• UDI-Public: 01008962410023431720052810PI170342
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: 5090885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Biomedical Engineer
• Device Expiration Date: 05/28/2020
• Device Model Number: 70-0285
• Device Lot Number: PI17/0342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1