MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-07 for CADD-SOLIS AMBULATORY INFUSION PUMP 2110 21-2111-0300-01 manufactured by Smiths Medical Asd, Inc..
[176242277]
Device evaluation: one smiths medical cadd-solis ambulatory infusion pump was returned for analysis in used condition. Visual inspection showed the tamper seal was missing and the battery compartment was broken. Functional testing involved sensor testing in addition to visual examination. The reported issue was not duplicated during the investigation. Based on the investigation, the complaint allegation was not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[176242278]
Information was received indicating that a smiths medical cadd-solis ambulatory infusion pump had an occlusion sensor issue. No adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-00063 |
| MDR Report Key | 9559470 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date Mfgr Received | 2019-12-10 |
| Device Manufacturer Date | 2018-10-02 |
| Date Added to Maude | 2020-01-07 |
| 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 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 3350 GRANADA AVE. N. SUITE 100 |
| Manufacturer City | OAKDALE MN 55128 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55128 |
| 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 | 2020-01-07 |
| Returned To Mfg | 2019-12-18 |
| Model Number | 2110 |
| Catalog Number | 21-2111-0300-01 |
| 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 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |