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

Model Number 70-0285

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2018

Event Type  malfunction  

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 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
• Type of Device: SYSTEM, WATER PURIFICATION, GENERAL MEDICAL U, PRODUCT CODE: NHV
• Manufacturer (Section D): NEPHROS INC; 380 lackawanna place; south orange NJ 07079
• Manufacturer (Section G): NEPHROS, INC.; 380 lackawanna; south orange NJ 07079
• Manufacturer Contact: vashone thomas ; 380 lackawanna place; south orange, NJ 07079 ; 2013450829
• MDR Report Key: 7397667
• MDR Text Key: 104542345
• Report Number: 3003337893-2018-00001
• Device Sequence Number: 1
• Product Code: NHV
• UDI-Device Identifier: 00896241002343
• UDI-Public: 01008962410023431720052810PI170342
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 5090885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1