MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03453)
MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03453) 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 | 3012307300-2020-03453 |
| 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 REMOVED BY THE BOTTOM CASE AND PLUNGER ASSEMBLY. THE RIGHT PLUNGER CASE WAS CRACKED. THE INVESTIGATOR ALSO NOTED A CRACK ON THE RIGHT PLUNGER CASE OF THE DEVICE. A REVIEW OF THE EVENT HISTORY LOG SHOWED THAT AN OCCLUSION TEST HAD BEEN RUN. THE INVESTIGATOR PERFORMED AN OCCLUSION TEST AND WA |
| Source | openFDA MAUDE (device adverse events) |
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