THERANOVA 400 Adverse Event — Malfunction (MDR 9611369-2020-00048)
THERANOVA 400 Adverse Event — Malfunction (MDR 9611369-2020-00048) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: THERANOVA 400; Generic name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE; Manufacturer: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER.
| Device | THERANOVA 400 |
|---|---|
| Generic name | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE |
| Manufacturer | BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER |
| Report number | 9611369-2020-00048 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | INITIAL REPORTER FACILITY NAME: (B)(6). INITIAL REPORTER PHONE NUMBER: (B)(6). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SU |
| Source | openFDA MAUDE (device adverse events) |
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