MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for MEDFUSION PUMP 3500 manufactured by Smiths Medical Asd, Inc..
[185903493]
One medfusion pump was received with the top and bottom cases in excellent condition and no visible contamination. The event history log was reviewed and a motor rate error was found in the history. An occlusion test was performed and a motor rate error was duplicated when using the same infusion rate as the user. The main printed circuit board (pcb) no longer operated as a result of normal wear; the pump was over 13 years old. The pcb was replaced to resolve the issue.
Patient Sequence No: 1, Text Type: N, H10
[185903494]
Information was received indicating that a smiths medical had a motor error and it was intermittent/ there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02622 |
| MDR Report Key | 9908384 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2006-07-14 |
| 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 NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| 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 | MEDFUSION PUMP |
| Generic Name | PUMP, INFUSION |
| Product Code | FRN |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-16 |
| Model Number | 3500 |
| 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 NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |