MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-21 for AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS MRO5 manufactured by Ameriwater.
[145972012]
Reverse osmosis machine constantly leaking due to corrosion in fittings made from brass. This leaded to high microbial to high microbial and lal count in product water used to dialyze pts. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086815 |
| MDR Report Key | 8632108 |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-04-27 |
| Date Added to Maude | 2019-05-22 |
| 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 PURIFICATION SYSTEM FOR HEMODIALYSIS |
| Generic Name | SUBSYSTEM, WATER PURIFICATION |
| Product Code | FIP |
| Date Received | 2019-05-21 |
| Model Number | MRO5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERIWATER |
| Manufacturer Address | 1257 STANLEY AVE DAYTON OH 45404 US 45404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-21 |