MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2020-02-25 for CADD SOLIS HPCA PUMP 2110 21-2111-0300-01 manufactured by Smiths Medical Asd, Inc..
[181132262]
One cadd solis hpca pump was received with a damaged lens. The event history log was reviewed and the reported problem was not found. Accuracy testing was conducted and the reported "failed accuracy" issue was unable to be confirmed. There was no fault found with the returned pump.
Patient Sequence No: 1, Text Type: N, H10
[181132263]
Information was received indicating that a smiths medical cadd solis hpca pump's pm and volume reading are off. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01472 |
| MDR Report Key | 9752324 |
| Report Source | CONSUMER,USER FACILITY |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2017-06-06 |
| Date Added to Maude | 2020-02-25 |
| 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 | CADD SOLIS HPCA PUMP |
| Generic Name | PUMP, INFUSION, PCA |
| Product Code | MEA |
| Date Received | 2020-02-25 |
| Returned To Mfg | 2020-02-06 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |