NI Adverse Event — Malfunction (MDR 1416980-2020-02419)
NI Adverse Event — Malfunction (MDR 1416980-2020-02419) 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 | 1416980-2020-02419 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, CONSUM |
| Narrative | AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS REPORTED. THE DEVICE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, A DISCONNECTION WAS REPORTED BETWEEN THE SUPPLY LINE OF THE HOMECHOICE CASSETTE AND THE SUPPLY BAG, WHICH IS KNOWN TO CAUSE THIS ALARM. THE CAUSE OF THE DISCONNECTION COULD NOT BE DETERMINED. SH |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →