MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-05 for CADD-SOLIS VIP AMBULATORY INFUSION PUMP 2110 21-2111-0100-51 manufactured by Smiths Medical Asd, Inc..
[177846841]
Device evaluation: one smiths medical cadd-solis ambulatory infusion pump was returned for analysis. Visual inspection showed the tamper seal was missing and the lens was damaged. Functional testing involved accuracy testing and showed the device duplicated the reported issue. The investigation determined that the expulsor being out of specification was the cause of the reported issue. The expulsor was replaced. Based on evidence and investigation, the complaint allegation was confirmed.
Patient Sequence No: 1, Text Type: N, H10
[177846842]
Information was received indicating that a smiths medical cadd-solis ambulatory infusion pump failed accuracy by over "+6%. " no adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-00623 |
| MDR Report Key | 9671621 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-05 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2013-06-10 |
| Date Added to Maude | 2020-02-05 |
| 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 VIP AMBULATORY INFUSION PUMP |
| Generic Name | PUMP, INFUSION, PCA |
| Product Code | MEA |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2020-01-13 |
| Model Number | 2110 |
| Catalog Number | 21-2111-0100-51 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-02-05 |