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 CADD LEGACY 1 INFUSION SYSTEM 6400 21-6400-51 manufactured by Smiths Medical Asd, Inc..
[185929509]
Returned device was received in fair physical condition and there was a cracked housing. Evidence of reported problem in event log was found. During the evaluation of the device, the issue was able to be replicated. Analysts were able to clear the code. The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution. No issues were identified that would have impacted this event.
Patient Sequence No: 1, Text Type: N, H10
[185929510]
Information was received indicating that a smiths medical cadd legacy pump was presenting with error 1310. There were no adverse events reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02512 |
| MDR Report Key | 9908440 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2010-10-20 |
| 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 | 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 LEGACY 1 INFUSION SYSTEM |
| Generic Name | PUMP, INFUSION |
| Product Code | FRN |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-06 |
| 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 |