MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2020-03-14 for DUODOPA PUMP 1400 21-1400-175 manufactured by Smiths Medical Asd,inc.
[183473744]
Investigation completed on a smiths medical duodpa pump. The ehl history revealed alarm of lec 1836 which is isolated to the optical switch. Also high 'pressure alarm' was in the record. Preventative measures to replace the dso sensor. The dhr revealed no discrepancies. Unknown cause of event.
Patient Sequence No: 1, Text Type: N, H10
[183473745]
Information received from abbvie 1562564 duodopa pump was involved with a event were a consumer of the pump was experiencing dyskinesia and bradykinesia which are listed side effect of medication being infused in the duodopa pump. Is was updated that their was no quality problem with the pump, but the physician suspected that there was an issue, so the pump was replaced do to concern,. Do to not knowing if the pump was overdosing or underdosing , this file will be reportable. As over dosing can cause cardiac events, along with hypotension and underdose can cause exacerbation of parkinsons disease. This in turn can cause patient have loss of motor skills, which would cause increase risk for fall and injury. No information on how the pump was programed. The pump is not a cure for the disease but an aide to lessen the uncontrolled motor response the disease manifest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01834 |
| MDR Report Key | 9832620 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2020-03-14 |
| Date of Report | 2020-03-13 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2018-01-08 |
| Date Added to Maude | 2020-03-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | DUODOPA PUMP |
| Generic Name | PUMP, INFUSION, ENTERAL |
| Product Code | LZH |
| Date Received | 2020-03-14 |
| Returned To Mfg | 2020-03-09 |
| Model Number | 1400 |
| Catalog Number | 21-1400-175 |
| 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 MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-14 |