MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-18 for CADD SOLIS AMBULATORY INFUSION 2110 21-2111-0100-51 manufactured by Smiths Medical Asd, Inc.
[184040593]
One cadd solis hpca pump was returned for analysis in good condition. The customer's stated problem was verified. The pump was inspected and when the cassette was attached onto the device it alarmed "cassette not attached properly". Further investigation of the pump determined that fluid ingression was the cause of the issue. The downstream occlusion sensor will be replaced.
Patient Sequence No: 1, Text Type: N, H10
[184040594]
Information was received indicating that a smiths cadd solis hpca ambulatory infusion pump displayed an alarm that the cassette is not attached. There was no reported injury or adverse events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02090 |
| MDR Report Key | 9850412 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2011-10-07 |
| Date Added to Maude | 2020-03-18 |
| 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 | MINNEAPLOIS, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CADD SOLIS AMBULATORY INFUSION |
| Generic Name | PUMP, INFUSION |
| Product Code | MEA |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-02-18 |
| 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 | 2020-03-18 |