MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03447)
MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03447) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MEDFUSION; Generic name: PUMP, INFUSION; Manufacturer: ST PAUL.
| Device | MEDFUSION |
|---|---|
| Generic name | PUMP, INFUSION |
| Manufacturer | ST PAUL |
| Report number | 3012307300-2020-03447 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | USER FACILITY |
| Narrative | EVALUATION RESULTS: ONE MEDFUSION PUMP WAS RETURNED FOR INVESTIGATION IN USED CONDITION. THE TAMPER SEAL WAS INTACT. THE RIGHT PLUNGER CASE WAS CRACKED. A REVIEW OF THE EVENT HISTORY LOG EVIDENCED SEVERAL MOTOR RATE ERRORS. THE REPORTED MOTOR RATE ERROR WAS REPLICATED DURING TESTING. AN INTERMITTENT ERROR WAS OBSERVED. THE INVESTIGATOR WAS UNABLE TO DETERMINE THE SOURCE OF THE ERROR. ALL OF THE MO |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →