MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor report with the FDA on 2020-03-31 for CADD LEGACY 1 PUMP 6400 21-6400-51 manufactured by Smiths Medical Asd, Inc..
[185904297]
One cadd legacy 1 pump was returned for analysis. The event history log was reviewed and there was no evidence of the reported issue. Three separate delivery accuracy tests were performed and the pump was visually inspected. The reported issue was unable to be confirmed. Delivery accuracy testing found the pumps average delivery error to be within the published specification of +/-6%. However, fluid ingressions were found on the pump by the chassis base of the expulsor, valves and occlusion sensors. The "failed accuracy -9. 65%" issue was possibly caused by fluid ingressions that damaged the gasket. It was recommend that the expulsor assembly be replaced as a preventative measure.
Patient Sequence No: 1, Text Type: N, H10
[185904298]
Information was received indicating that a smiths medical cadd legacy 1 pump failed accuracy by -9. 65% during testing. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02549 |
| MDR Report Key | 9908365 |
| Report Source | CONSUMER,DISTRIBUTOR |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2003-04-28 |
| 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 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 LEGACY 1 PUMP |
| Generic Name | PUMP, INFUSION |
| Product Code | FRN |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-09 |
| Model Number | 6400 |
| Catalog Number | 21-6400-51 |
| 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 | 2020-03-31 |