MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-20 for MEDFUSION 3500 SYRINGE PUMP 3500-306 manufactured by .
[139409401]
It was reported that the device had a "motor failure" error. No known adverse effects to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-01444 |
| MDR Report Key | 8438745 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-20 |
| Date of Report | 2019-04-29 |
| Date Mfgr Received | 2019-04-03 |
| Device Manufacturer Date | 2006-11-14 |
| Date Added to Maude | 2019-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVID HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH 1820 14TH ST |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer G1 | NULL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDFUSION 3500 SYRINGE PUMP |
| Product Code | MRZ |
| Date Received | 2019-03-20 |
| Returned To Mfg | 2019-03-05 |
| Catalog Number | 3500-306 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-20 |