MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-28 for CADD-LEGACY 1 AMBULATORY INFUSION PUMP 21-6400-51 manufactured by .
[137446954]
Other, other text: device evaluation- the device was returned for evaluation. The returned device was given functional testing. After power up, the device gave an error alarm with the message "error 1720". This type of error can indicate an issue with the backup capacitor. The backup capacitor was replaced to address this issue. The cause of the issue with the component was not established.
Patient Sequence No: 1, Text Type: N, H10
[137446955]
It was reported that the device gave an error alarm with message of "error 1720'. No known adverse effects to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-00884 |
| MDR Report Key | 8379254 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-28 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-01-25 |
| Date Mfgr Received | 2019-03-06 |
| Device Manufacturer Date | 2018-12-03 |
| Date Added to Maude | 2019-02-28 |
| 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 | DAVID HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer G1 | NULL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CADD-LEGACY 1 AMBULATORY INFUSION PUMP |
| Generic Name | PUMP, INFUSION |
| Product Code | FRN |
| Date Received | 2019-02-28 |
| Returned To Mfg | 2019-02-04 |
| Catalog Number | 21-6400-51 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-28 |