MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-25 for CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP 1400 21-1401-01 manufactured by Smiths Medical Asd, Inc..
[184998064]
Information was received indicating that during use of a smiths medical cadd-legacy duodopa ambulatory infusion pump, the morning dose infused "over about five minutes" and the patient would "like to slow it down. " per reporter it is not known if the patient's pump is programmed correctly or if the pump is delivering the prescribed dosage correctly or not. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02327 |
| MDR Report Key | 9878153 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2016-01-05 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| Model Number | 1400 |
| Catalog Number | 21-1401-01 |
| 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 | 2020-03-25 |