MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03417)
MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03417) 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 | 3012307300-2020-03417 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | ONE MEDFUSION PUMP WAS RECEIVED WITH THE TOP CASE CRACKED AND CHIPPED. THE BOTTOM CASE HAD SEAL DAMAGE. THE EVENT HISTORY LOG WAS REVIEWED AND THERE WAS AN INVALID SYRINGE SIZE ALARM. THE PUMP WAS SET UP FOR FLOW TEST AND THE REPORTED ISSUE WAS ABLE TO BE REPLICATED. THERE WAS CONTAMINATION ON THE SIZE POT. THIS ISSUE WAS CUSTOMER INDUCED VIA FLUID INGRESSION INTO THE MAIN BODY OF THE PUMP AS A RE |
| Source | openFDA MAUDE (device adverse events) |
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