MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-08-01 for WRO 300H manufactured by Mar Cor Purification.
[4608700]
Customer contacted mar cor (mcp) to report their portable reverse osmosis machines were leaking with water going into adjacent rooms. Patient treatment delayed.
Patient Sequence No: 1, Text Type: D, B5
[12072443]
The customer stated that some treatments were delayed due to the leaking. Replacement valves were shipped for all 11 machines because customer could not identify which machines were leaking. The leaking part(s) was a backflow preventer on the incoming supply water to the portable ro machines. This backflow preventer is not part of the device but was installed on their incoming water lines at the customer's request to meet local plumbing code requirements. Measurement of the incoming water supply showed wide pressure fluctuations from 20psi to 60 psi on a routine basis. A backflow preventer specialist is evaluating to identify a different valve to utilize. This will be monitored within marcor purification complaint system. If additional information is received, this complaint will be evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019131-2014-00024 |
| MDR Report Key | 3973173 |
| Report Source | 05,06 |
| Date Received | 2014-08-01 |
| Date of Report | 2014-08-01 |
| Date of Event | 2014-07-03 |
| Date Mfgr Received | 2014-07-03 |
| Date Added to Maude | 2014-08-12 |
| 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 | WRO 300H |
| Generic Name | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
| Product Code | FIP |
| Date Received | 2014-08-01 |
| Operator | OTHER |
| 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 | 2014-08-01 |