MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-07 for WRO 300H DIALYSIS WATER SYSTEM RO,WRO 300 H,115V~,60HZ manufactured by Mar Cor Purification, Inc..
[72096117]
Patient Sequence No: 1, Text Type: N, H10
[72096118]
Portable hemodialysis (water treatment) reverse osmosis(ro) are cultured and tested for endotoxins monthly. In the beginning of the year, all portable ro machines; marcor model wro300h were pulled from use due to culture and endotoxin results. Contacted the manufacturer to see what can be done to eliminate frequent positive cultures. Recommended to increase heat disinfectant process from 2x/week to once per day. With new process, all ros had no growth in past two months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6471592 |
| MDR Report Key | 6471592 |
| Date Received | 2017-04-07 |
| Date of Report | 2017-03-20 |
| Date of Event | 2017-01-16 |
| Report Date | 2017-03-20 |
| Date Reported to FDA | 2017-03-20 |
| Date Reported to Mfgr | 2017-03-20 |
| Date Added to Maude | 2017-04-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WRO 300H DIALYSIS WATER SYSTEM |
| Generic Name | SUBSYSTEM, WATER PURIFICATION |
| Product Code | FIP |
| Date Received | 2017-04-07 |
| Model Number | RO,WRO 300 H,115V~,60HZ |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAR COR PURIFICATION, INC. |
| Manufacturer Address | 14550 28TH AVENUE NORTH MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-07 |