MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-04-04 for DSU-H 70-0285 manufactured by Nephros Inc.
[104542345]
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.
Patient Sequence No: 1, Text Type: N, H10
[104542346]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003337893-2018-00001 |
| MDR Report Key | 7397667 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-04 |
| Date of Report | 2018-04-04 |
| Date of Event | 2018-01-25 |
| Date Mfgr Received | 2018-01-25 |
| Date Added to Maude | 2018-04-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. VASHONE THOMAS |
| Manufacturer Street | 380 LACKAWANNA PLACE |
| Manufacturer City | SOUTH ORANGE NJ 07079 |
| Manufacturer Country | US |
| Manufacturer Postal | 07079 |
| Manufacturer Phone | 2013450829 |
| Manufacturer G1 | NEPHROS, INC. |
| Manufacturer Street | 380 LACKAWANNA |
| Manufacturer City | SOUTH ORANGE NJ 07079 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07079 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DSU-H |
| Generic Name | SYSTEM, WATER PURIFICATION, GENERAL MEDICAL U, PRODUCT CODE: NHV |
| Product Code | NHV |
| Date Received | 2018-04-04 |
| Returned To Mfg | 2018-02-07 |
| Model Number | 70-0285 |
| Lot Number | PI17/0342 |
| Operator | BIOMEDICAL ENGINEER |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEPHROS INC |
| Manufacturer Address | 380 LACKAWANNA PLACE SOUTH ORANGE NJ 07079 US 07079 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-04 |