FDA Adverse Event
Malfunction
Summary report: N
CADD LEGACY PUMP
MDR report key: 8713659
·
Received June 19, 2019
Report
- Report Number
- 3012307300-2019-03351
- Event Type
- Malfunction
- Date Received
- June 19, 2019
- Report Date
- June 19, 2019
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- UDI-DI
- 10610586019548
- PMA / PMN Number
- K982838
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ONE CADD LEGACY PUMP WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION PERFORMED, AND PRODUCT FOUND IN DAMAGE CONDITION. EVENT HISTORY LOG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF REPORTED PROBLEM. DURING INVESTIGATION THE CASSETTE WAS ATTACHED TO THE DEVICE AND RAN WITH NO ISSUES. INVESTIGATION COULD NOT DUPLICATE THE "NO DISPOSABLE" ALARMS. SERVICE'S RECALIBRATE THE UPSTREAM SENSOR AND REPLACED THE DOWNSTREAM SENSOR AS PREVENTIVE MEASURE. NO FAULT FOUND.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT THIS SMITHS MEDICAL CADD LEGACY PUMP EXHIBITED NDA ALARM AFTER NDA FIRMWARE COMPLETED. IT WAS NOT SPECIFIED WHETHER THIS OCCURRED DURING INFUSION OR INTERRUPTED THERAPY. NO REPORTED ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 505738 | CADD LEGACY PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 6400 | 10610586019548 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |