MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03457)
MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03457) 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 | 3012307300-2020-03457 |
| 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. THE RIGHT PLUNGER CASE WAS CRACKED. THE TOP CASE WAS CHIPPED AND CRACKED. THERE WAS MOTOR RATE ERROR IN HISTORY. MULTIPLE FLOW AND OCCLUSION TESTS WERE PERFORMED. THE CUSTOMER REPORTED PRODUCT PROBLEM REGARDING THE MOTOR RATE ERROR WAS NOT REPLICATED DURING TESTING. THE PROBLEM SOU |
| Source | openFDA MAUDE (device adverse events) |
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