MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP 1400 21-1400-03 manufactured by Smiths Medical Asd, Inc..
[185740142]
Information was received indicating that a smiths medical cadd-legacy duodopa ambulatory infusion pump was "accidentally programmed and saved the continuous day rate to 4. 5 ml/h instead of 2. 1ml/h in the morning when switching from night to day rate. " it was reported that the nursing staff was subsequently trained. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02582 |
| MDR Report Key | 9903702 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2017-10-17 |
| 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 AVE. N. 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 DUODOPA AMBULATORY INFUSION PUMP |
| Generic Name | PUMP, INFUSION, ENTERAL |
| Product Code | LZH |
| Date Received | 2020-03-31 |
| Model Number | 1400 |
| Catalog Number | 21-1400-03 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 |