MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-04 for CADD-SOLIS AMBULATORY INFUSION PUMP 2110 21-2111-0100-51 manufactured by Smiths Medical Asd, Inc..
[182011998]
Device evaluation: one smiths medical cadd-solis ambulatory infusion pump was returned for analysis in used condition. Review of the event history log showed the pump displayed an occurrence of a downstream occlusion alarm. Functional testing involved visually inspecting the pump and showed that there was fluid on the downstream occlusion sensor which could cause the pump to have an issue with priming. The investigation determined that fluid ingression was the cause of the reported issue. The downstream occlusion sensor was replaced. Based on evidence and investigation, the complaint allegation was confirmed.
Patient Sequence No: 1, Text Type: N, H10
[182011999]
Information was received indicating that a smiths medical cadd-solis ambulatory infusion pump was unable to prime. No adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01827 |
| MDR Report Key | 9788033 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2012-04-17 |
| Date Added to Maude | 2020-03-04 |
| 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 AVE. N. 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 | CADD-SOLIS AMBULATORY INFUSION PUMP |
| Generic Name | PUMP, INFUSION, PCA |
| Product Code | MEA |
| Date Received | 2020-03-04 |
| Returned To Mfg | 2020-02-14 |
| Model Number | 2110 |
| Catalog Number | 21-2111-0100-51 |
| 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 | 2020-03-04 |