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 2020-03-11 for CADD DUODOPA PUMP 1400 21-1400-03 manufactured by Smiths Medical Asd,inc.
[182962432]
Investigation results completed on a cadd duodopa pump. The complaint of insufficient gel being infused was not confirmed. The device investigation revealed n log that the device was delivering with in specification. Testing could not verify or duplicate report. Unknown cause of event.
Patient Sequence No: 1, Text Type: N, H10
[182962433]
Information received a smiths medical cadd-legacy duodopa 1400 pump reported the correct amount of gel (medication). Unclear of under delivery or over delivery. Over delivery may or could cause risk for cardiovascular event or hypotension. No reports on patient having adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01832 |
| MDR Report Key | 9817809 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2017-10-03 |
| Date Added to Maude | 2020-03-11 |
| 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 | 2020-03-11 |
| Returned To Mfg | 2020-02-25 |
| Model Number | 1400 |
| Catalog Number | 21-1400-03 |
| Device Expiration Date | 2017-10-03 |
| Operator | LAY USER/PATIENT |
| 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 | 1. Other | 2020-03-11 |