MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP 1400 21-1400-51 manufactured by Smiths Medical Asd, Inc..
[185724376]
Information was received indicating that a patient who was receiving duodopa treatment with a cadd-legacy duodopa ambulatory infusion pump was in the hospital for five weeks and their pump was "usually switched off at 10 pm. However, last night patient's husband didn't stay overnight, and the nursing staff left the pump running over night. " per reporter the husband reported that the patient was "having more frequent convulsions" that were "lasting longer each time, and she is being given an injection that makes her sleepy after fitting. " it was reported that no cause had been found, but the staff was investigating. The husband reported that the pump showed a total infusion volume over twenty-four (24) hours as "4610 mg. " per reporter, the husband was advised to keep the patient off of the pump if they were showing signs of "on symptoms. " it was reported that the husband was advised that the sleepiness could be caused by the medication, and it was "difficult to say if it's due to the extra dose of duodopa. " it was also reported that the husband "came to see the patient around 10:30 am and morning dose is usually given at 8-8:30 am. And duadopa pump has only been switched off for 1 hour. " the husband was advised by the reporter to speak with the hospital doctors and consultants there regarding switching the pump off and keeping it off. Additional information was received indicating that the patient has passed away. Per reporter, the cause of the death was unreported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02583 |
| MDR Report Key | 9903693 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2015-04-10 |
| Date Added to Maude | 2020-03-31 |
| 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 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 3350 GRANADA AVE. N. 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-LEGACY DUODOPA AMBULATORY INFUSION PUMP |
| Generic Name | PUMP, INFUSION, ENTERAL |
| Product Code | LZH |
| Date Received | 2020-03-31 |
| 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 NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-31 |