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 3500-414 manufactured by Smiths Medical Asd, Inc..
[185905862]
One medfusion pump was received with a damaged right plunger case. The event history log was reviewed and there was a "check plunger lever" alarm in the history. Flow and occlusion tests were performed and the reported issue was able to be replicated. The clutch half's left and right with leadscrew and spring were replaced to resolve the issue. The issue was caused by normal wear as the parts were over 6 years old.
Patient Sequence No: 1, Text Type: N, H10
[185905863]
Information was received indicating that a smiths medical medfusion pump failed occlusion test, made a popping sound and had a "check plunger clutch" message. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02624 |
| MDR Report Key | 9908364 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2007-02-23 |
| 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 | 3500-414 |
| 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 |