MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-02-15 for MILLENIUM HX manufactured by Mar Cor Purification.
[136457932]
The facility reported observing a brown substance on the reverse osmosis (ro) membrane in their millenium hx portable ro system. There is potential for patient or user exposure. The facility immediately replaced the affected membrane in their ro system and has not experienced any issues. The source of the brown substance was confirmed to be the adhesive used in the construction of the membrane itself. It is unknown if the substance is entering the ro system fluid pathway. Additional testing and investigation is underway. There have been no reports of any patient adverse effects. This report is being submitted conservatively as the potential for patient or user exposure to the substance is unknown at this time. This complaint will continue being monitored in the mar cor purification/cantel complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[136457933]
The facility reported observing a brown substance on the reverse osmosis (ro) membrane in their millenium hx portable ro system. There is potential for patient or user exposure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2019-00002 |
| MDR Report Key | 8345765 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2015-10-23 |
| Date Added to Maude | 2019-02-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALEX NELSON |
| Manufacturer Street | 14550 28TH AVENUE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635094799 |
| Manufacturer G1 | MAR COR PURIFICATION |
| Manufacturer Street | 14550 28TH AVENUE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILLENIUM HX |
| Generic Name | WATER PURIFICATION SYSTEM |
| Product Code | FIP |
| Date Received | 2019-02-15 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAR COR PURIFICATION |
| Manufacturer Address | 14550 28TH AVENUE NORTH MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-15 |