MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-10 for CADD DUODOPA PUMP 1400 21-1401-01 manufactured by Smiths Medical Asd,inc.
[182770649]
Information received a smiths medical cadd-legacy duodopa 1400 pump was reporting ongoing issues with toes curling up and taste of medication in mouth. It was then reported the pump was stopped for two hour and symptoms resolved. The concern for over delivery, this file is considered reportable, for medication in high doses can cause complications but mostly concerned with cardiovascular system and hypotension in high doses. Patient requested replacement pump and this was initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01828 |
| MDR Report Key | 9812700 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2016-02-25 |
| Date Added to Maude | 2020-03-10 |
| 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 LANE N |
| 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 DUODOPA PUMP 1400 |
| Generic Name | PUMP, INFUSION, ENTERAL |
| Product Code | LZH |
| Date Received | 2020-03-10 |
| 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 MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-10 |