MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-28 for CENTURION 1500 L998374 manufactured by Ameriwater.
[27454626]
Endotoxin membrane casing on centurion 15000 from ameriwater fractured and water streaming out from inside the machine. Patient being dialyzer at the time lost more than 200ml's of blood and dialysis and was discontinued from a result of the mobile reverse osmosis machine failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056756 |
| MDR Report Key | 5123940 |
| Date Received | 2015-09-28 |
| Date of Report | 2015-09-28 |
| Date of Event | 2015-09-15 |
| Date Added to Maude | 2015-10-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | CENTURION 1500 |
| Generic Name | NONE |
| Product Code | FIP |
| Date Received | 2015-09-28 |
| Returned To Mfg | 2015-09-23 |
| Model Number | L998374 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERIWATER |
| Manufacturer Address | DAYTON OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-28 |