MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-10 for WATER PURIFICATION SYSTEM FOR HEMODIALYSIS 100474 manufactured by Mar Cor Purification.
[21495841]
Facility accidentally started a water softener regeneration which caused the cwp ro unit to alarm due to high conductivity. Patients had treatment delayed for 10 minutes while the cwp was flushed/cleaned.
Patient Sequence No: 1, Text Type: D, B5
[21687457]
The facility reported they were working on the water softener with the lock out wire off. A water softener manual regeneration cycle was accidentally started allowing the softener to uptake brine. The cwp ro system pulled in some brine and alarmed high conductivity, causing ro water production to shut down. 17 patents were delayed treatment for 10 minutes while the cwp was flushed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019131-2014-00027 |
| MDR Report Key | 4163582 |
| Report Source | 05,06 |
| Date Received | 2014-10-10 |
| Date of Report | 2014-10-10 |
| Date of Event | 2014-09-12 |
| Date Mfgr Received | 2014-09-12 |
| Device Manufacturer Date | 2014-09-07 |
| Date Added to Maude | 2014-10-10 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
| Generic Name | REVERSE OSMOSIS SYSTEM |
| Product Code | FIP |
| Date Received | 2014-10-10 |
| Model Number | 100474 |
| 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 | 2014-10-10 |