MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-12-29 for CWP 101366 manufactured by Mar Cor Purification.
[34594411]
New information provided by clinic on 11/19/2015, user report mw5058085. A clinic employee pulled the fire alarm when smoke was noticed in the water room, not the patient area. Ro unit was repaired and patients resumed treatment after an approximate 15 minute delay. To date, there have been no reports of illness or injury. This complaint will continue to be monitored in the mar cor complaint handling system. Solenoid valve disposed of by user.
Patient Sequence No: 1, Text Type: N, H10
[34594412]
On (b)(6) 2015 dialysis clinic informed mar cor that their inlet solenoid coil stopped functioning on (b)(6) 2015. A 15 minute delay of patient treatment for 10 patients was reported while repairs were performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2015-00006 |
| MDR Report Key | 5332485 |
| Report Source | USER FACILITY |
| Date Received | 2015-12-29 |
| Date of Report | 2015-12-18 |
| Date of Event | 2015-05-16 |
| Date Mfgr Received | 2015-03-19 |
| Device Manufacturer Date | 2014-07-21 |
| Date Added to Maude | 2015-12-29 |
| 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 |
| 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 | 2015-12-29 |
| Model Number | 101366 |
| 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 | 2015-12-29 |