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 2020-01-06 for CADD SOLIS HPCA PUMP 2110 21-2112-0100-51 manufactured by Smiths Medical Asd, Inc..
[176118941]
One cadd solis hpca pump was received with no physical damage. No issue was found in the event history log. Accuracy test was performed on the pump. The pump was previously returned due to an allegation that it "kept infusing when trying to stop", which was not verified. The delivery accuracy tests found the pump to be within the published specification of +/-6%. The pump's expulsor will be replaced as a preventive measure to bring the delivery into more nominal of a range. The reported issue could not be replicated and the cause of the issue is unknown.
Patient Sequence No: 1, Text Type: N, H10
[176118942]
Information was received indicating that a smiths medical cadd solis hpca pump was over infusing. The issue was discovered during preventative maintenance and there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-00108 |
| MDR Report Key | 9555027 |
| Report Source | CONSUMER,USER FACILITY |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date Mfgr Received | 2019-12-11 |
| Device Manufacturer Date | 2012-12-28 |
| Date Added to Maude | 2020-01-06 |
| 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 | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| 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 | 2020-01-06 |
| Returned To Mfg | 2019-12-13 |
| Model Number | 2110 |
| Catalog Number | 21-2112-0100-51 |
| 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 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-06 |