MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-31 for CWP 101366 102H manufactured by Mar Cor Purification.
[5753388]
Dialysis clinic received no water source alarms and had some smoke in the water treatment room. Patient treatment delay of approximately 30 minutes while repairs were performed.
Patient Sequence No: 1, Text Type: D, B5
[13098517]
The ro system shut down when the water inlet solenoid valve failed to remain open. Fire department was called due to some smoke (from the failed valve) in the water treatment room. 10 patients were on dialysis at the time, 6 were near the end of treatment and 4 resumed treatment after the valve was replaced. The ro system was repaired in approximately 30 minutes. No patient or worker injuries were reported. Mar cor will continue to monitor this complaint with in the complaint system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019131-2015-00001 |
| MDR Report Key | 4644558 |
| Report Source | 06 |
| Date Received | 2015-03-31 |
| Date of Report | 2015-03-31 |
| Date of Event | 2015-03-03 |
| Date Mfgr Received | 2015-03-04 |
| Device Manufacturer Date | 2014-07-21 |
| Date Added to Maude | 2015-05-04 |
| 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 |
| 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 | CWP |
| Generic Name | REVERSE OSMOSIS SYSTEM |
| Product Code | FIP |
| Date Received | 2015-03-31 |
| Model Number | 101366 |
| Catalog Number | 102H |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-03-31 |