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 2020-03-17 for DUODOPA PUMP 1400 21-1400-51 manufactured by Smiths Medical Asd,inc.
[183873729]
Information received from abbvie 1562564 duodopa pump was involved with a event were reported by nurse the pump was left on the patient all night , causing over-delivery of medication. No patient adverse events reported. This file will be reportable, as over dosing can cause cardiac events, along with hypotension.. The pump is not a cure for the disease but an aide to lessen the uncontrolled motor response the disease manifest. Over-delivery may cause harm to the patient as above listed events could occur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01999 |
| MDR Report Key | 9845150 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-17 |
| 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 | 2020-03-17 |
| Model Number | 1400 |
| Catalog Number | 21-1400-51 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-17 |