MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-20 for 23G CENTRAL DIALYSIS REVERSE OSMOSIS WATER SYSTEM manufactured by Mar Cor Purification.
[5298283]
Customer has reported lower flow rates and increased cleaning frequency after installing new reverse osmosis membranes in their central water system. The low flow resulted in the need delay patient treatment while waiting for di tanks to be delivered.
Patient Sequence No: 1, Text Type: D, B5
[12540778]
The clinic had to delay patient treatment due to low flow (3. 2 gpm) following a low/high membrane cleaning and disinfect. Sdi and toc tests were completed with no abnormal results. Water softener is reported to be working correctly with twice daily testing. 58 patients had treatment delayed and the clinic confirmed there were no medical consequences related to the delay. There were no reports of patient illness or injury as a result of this incident. This complaint will continue to be maintained within mar cor purification's complaint system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019131-2014-00031 |
| MDR Report Key | 4267455 |
| Report Source | 05,06 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-11-20 |
| Date of Event | 2014-10-22 |
| Date Mfgr Received | 2014-10-22 |
| Date Added to Maude | 2014-12-02 |
| 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 | 0 |
| Event Location | 0 |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 23G CENTRAL DIALYSIS REVERSE OSMOSIS WATER SYSTEM |
| Generic Name | CENTRAL WATER TREATMENT SYSTEM |
| Product Code | FIP |
| Date Received | 2014-11-20 |
| Model Number | 23G |
| 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 | 2014-11-20 |