MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-01 for MARCOR WATER PURIFICATION SYSTEM 3024326 manufactured by Marcor Purification.
[23008138]
Staff recorded a chlorine level of >0. 1ppm in the water reservoir. Pts taken off dialysis early and blood in extracorporeal circuit not returned to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5001394 |
| MDR Report Key | 5001394 |
| Date Received | 2015-07-01 |
| Date of Report | 2015-06-25 |
| Date of Event | 2015-06-21 |
| Date Facility Aware | 2015-06-21 |
| Report Date | 2015-06-25 |
| Date Reported to FDA | 2015-06-30 |
| Date Added to Maude | 2015-08-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | MARCOR WATER PURIFICATION SYSTEM |
| Generic Name | INDIRECT FEED SYSTEM WITH DUAL 23G ROS |
| Product Code | FIP |
| Date Received | 2015-07-01 |
| Model Number | 3024326 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARCOR PURIFICATION |
| Manufacturer Address | PLYMOUTH MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2015-07-01 |