MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-31 for SMITHS MEDICAL CADD SOLIS VIP PUMP 2120 21-2120-0102-51 manufactured by Smiths Medical Asd, Inc..
[185920831]
One infusion pump was returned for evaluation. Visual inspection of the device found it to be in good physical condition. A dhr review was performed subsequent to the manufacturing of the device and prior to its release. No problems or issues were identified during this dhr review. Device underwent delivery accuracy testing; the customer's reported problem regarding delivery accuracy was unable to be duplicated. Three separate delivery accuracy tests were per formed. All were within the pump's delivery accuracy manufacturing specifications of +/-6 percent. No problems were found with the delivery accuracy of the pump.
Patient Sequence No: 1, Text Type: N, H10
[185920832]
Information was received that a smiths medical ambulatory infusion cadd solis vip pump is not delivering anything. No adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02253 |
| MDR Report Key | 9907631 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2014-12-18 |
| Date Added to Maude | 2020-03-31 |
| 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 N |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| 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 | SMITHS MEDICAL CADD SOLIS VIP PUMP |
| Generic Name | PUMP, INFUSION |
| Product Code | FRN |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-03 |
| Model Number | 2120 |
| Catalog Number | 21-2120-0102-51 |
| 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 N MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |