MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other,user facili report with the FDA on 2020-03-12 for DUODOPA PUMP 1400 21-1400-51 manufactured by Smiths Medical Asd,inc.
[183251011]
Investigation results completed on a duodopa 1400 infusion pump. The investigation found no problems with the flow rate of delivering nor setting the lock level. When the pump testing was done , this revealed the device was within specification. The ehl revealed 1660 code, which is a issue with the main board. Due to the device being three years and eight months old, it will not be repaired. Ehl data will be saved. The dhr revealed no problem prior to release of device.
Patient Sequence No: 1, Text Type: N, H10
[183251012]
Information received from abbvie 1563263 duodopa pump flow rate-not flowing correctly. Unable to set lock level. Unknown if patient involvement or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01833 |
| MDR Report Key | 9827536 |
| Report Source | DISTRIBUTOR,OTHER,USER FACILI |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2017-05-25 |
| Date Added to Maude | 2020-03-12 |
| 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 | 2020-03-12 |
| Returned To Mfg | 2020-02-24 |
| Model Number | 1400 |
| Catalog Number | 21-1400-51 |
| 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 | 2020-03-12 |