NI Adverse Event — Malfunction (MDR 1416980-2020-02413)
NI Adverse Event — Malfunction (MDR 1416980-2020-02413) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: NI; Generic name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY; Manufacturer: BAXTER HEALTHCARE CORPORATION.
| Device | NI |
|---|---|
| Generic name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Report number | 1416980-2020-02413 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, CONSUM |
| Narrative | H10: AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS REPORTED. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, AN UNSPECIFIED LEAK WAS REPORTED WITH THE USE OF THE HOMECHOICE CASSETTE, WHICH IS KNOWN TO CAUSE THIS ALARM. THE CAUSE OF THE LEAK COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT IN |
| Source | openFDA MAUDE (device adverse events) |
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