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.
[23008074]
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 | 5001400 |
MDR Report Key | 5001400 |
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 |