MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-30 for AMERIWATER MRO5X AMERIWATER PURIFICATION SYSTEM manufactured by Ameriwater Llc.
[146811349]
Water purification system for intended use in a dialysis setting has fittings that are made of brass. The brass fittings corrode and leak water. The leakage cause the membranes to lose their prime and system automatic flushing does not get initiated due to the pressure drop. The membranes and the water purification system due to not being flushed automatically stimulate bacterial growth, which becomes high and in an unacceptable numbers. There is potential that this will cause pts infections and pyrogenic reactions. The tests are performed on the purified water using bacterial colony counts in produced water for dialysis and lal (an assay that is used to estimate endotoxins in water) both tests giving numbers that are not acceptable for the product water. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5087032 |
| MDR Report Key | 8658442 |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-28 |
| Date of Event | 2019-04-29 |
| Date Added to Maude | 2019-05-31 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | AMERIWATER MRO5X AMERIWATER PURIFICATION SYSTEM |
| Generic Name | SUBSYSTEM, WATER PURIFICATION |
| Product Code | FIP |
| Date Received | 2019-05-30 |
| Model Number | MRO5X |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERIWATER LLC |
| Manufacturer Address | DAYTON OH 45414 US 45414 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-30 |