MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03433)
MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03433) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MEDFUSION; Generic name: PUMP, INFUSION; Manufacturer: SMITHS MEDICAL ASD, INC..
| Device | MEDFUSION |
|---|---|
| Generic name | PUMP, INFUSION |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Report number | 3012307300-2020-03433 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | ONE MEDFUSION PUMP WAS RECEIVED WITH A CRACK ON THE RIGHT PLUNGER CASE AND A MISSING PORTION OF THE BOTTOM CASE SEAL. THE EVENT HISTORY LOG WAS REVIEWED AND THERE WAS A FORCE SENSOR TEST ERROR. THE POWER UP PROCESS WAS CONDUCTED, THE FORCE SENSOR WAS ALSO CHECKED AND TESTED. A FORCE SENSOR ERROR WAS FOUND AT POWER UP AND THE FORCE SENSOR WAS UNABLE TO BE CALIBRATED. CONTAMINATION WAS FOUND INSIDE |
| Source | openFDA MAUDE (device adverse events) |
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