MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-31 for SMITHS MEDICAL MEDFUSION 3500 PUMPS manufactured by Smiths Medical Asd, Inc..
[185918335]
One medfusion pump was returned for evaluation. Visual inspection of the device found it be cracked on top case by the tube holders and includes a hand written serial number on the label. Primary audible alarm post error was noted in the event history log. Device was powered on, but the primary audible alarm post error was unable to be duplicated. It was unable to be determined the source of the intermittent error. The speaker was replaced for preventive measure. Pump noted to be over 14 years old. While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.
Patient Sequence No: 1, Text Type: N, H10
[185918336]
Information was received that a smiths medical medfusion syringe pump has system failure primary audible alarm. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02588 |
| MDR Report Key | 9907645 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2004-11-19 |
| Date Added to Maude | 2020-03-31 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 3350 GRANADA AVENUE NORTH SUITE 100 |
| Manufacturer City | OAKDALE, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITHS MEDICAL MEDFUSION 3500 PUMPS |
| Generic Name | PUMP, INFUSION |
| Product Code | FRN |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-09 |
| Catalog Number | 3500 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |