MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-17 for WATER PURIFICATION SYSTEM manufactured by Mar Cor Purification.
[18035286]
The reverse osmosis loop's pretreatment dealkalizer scavenger head was not functioning correctly which caused the cwp ro unit to alarm due to high conductivity. Patients had treatment delayed.
Patient Sequence No: 1, Text Type: D, B5
[18392077]
The facility reported they experienced a high conductivity alarm on their cwp ro system (percent rejection has dropped to (b)(4)). Upon inspection, the clinic found the reverse osmosis loop's pretreatment dealkalizer scavenger head was not functioning correctly. This allowed the cwp ro to intake some brine causing the high conductivity alarm and ro water production to shut down. The scavenger head was bypassed and the water conductivity began to fall. 16 patents were treatment delayed. 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 | 3019131-2014-00028 |
| MDR Report Key | 4180216 |
| Report Source | 05,06 |
| Date Received | 2014-10-17 |
| Date of Report | 2014-10-16 |
| Date of Event | 2014-09-19 |
| Date Mfgr Received | 2014-09-22 |
| Device Manufacturer Date | 2014-05-26 |
| Date Added to Maude | 2014-10-30 |
| 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 | WATER PURIFICATION SYSTEM |
| Generic Name | REVERSE OSMOSIS SYSTEM |
| Product Code | FIP |
| Date Received | 2014-10-17 |
| ID Number | 3028501 |
| 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 | 2014-10-17 |