MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-22 for OSMO 23G REVERSE OSMOSIS EQUIPMENT manufactured by Mar Cor Purification.
[4982979]
Clinic contacted mar cor to report their reverse osmosis water storage tank went dry causing a slight delay in patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[12211728]
The customer has to delay patient treatment (to 11 patients) due to lack of reverse osmosis water. Upon inspection it was discovered the permeate divert control box had a blown fuse. This caused all produced water to automatically divert to drain. Cause of the blown fuse in unknown and the issue was resolved after 30 minutes delay by replacing the fuse. Unit was produced in 1999. 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 | 3019131-2014-00029 |
| MDR Report Key | 4193758 |
| Report Source | 05,06 |
| Date Received | 2014-10-22 |
| Date of Report | 2014-10-22 |
| Date of Event | 2014-09-24 |
| Date Mfgr Received | 2014-09-24 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2014-10-22 |
| 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 | MEGAN DICKEY |
| Manufacturer Street | 14550 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533300 |
| Manufacturer G1 | MAR COR PURIFICATION |
| Manufacturer Street | 14550 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSMO 23G REVERSE OSMOSIS EQUIPMENT |
| Generic Name | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
| Product Code | FIP |
| Date Received | 2014-10-22 |
| 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 AVE N MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-22 |