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 2015-09-25 for MILLENIUM RO SYSTEM manufactured by Mar Cor Purification.
[26758087]
On (b)(6), dialysis clinic accidentally connected the product water line to the disinfection port of the portable ro system (ports are color coded, unit manufactured prior to 2005). One patient was dialyzed with de-chlorinated water that had not been treated by the reverse osmosis water system. Clinic tested the water and found elevated sodium and fluoride levels. No patient or worker injuries were reported. This complaint will continue to be maintained within the mar cor complaint system.
Patient Sequence No: 1, Text Type: N, H10
[26758088]
Patient was dialyzed utilizing de-chlorinated water that has not been processed by the portable ro system. Biomed manager was not aware of any patient issues (one patient).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2015-00004 |
| MDR Report Key | 5104050 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-09-25 |
| Date of Report | 2015-09-25 |
| Date of Event | 2015-08-27 |
| Date Mfgr Received | 2015-08-27 |
| Device Manufacturer Date | 2004-12-31 |
| Date Added to Maude | 2015-09-25 |
| 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 | MS. MEGAN DICKEY |
| Manufacturer Street | 14550 28TH AVENUE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533300 |
| 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 RO SYSTEM |
| Generic Name | WATER PURIFICATION SYSTEMS AND PORTABLE REVERSE OSMOSIS SYSTEMS |
| Product Code | FIP |
| Date Received | 2015-09-25 |
| Model Number | MILLENIUM |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-09-25 |