CADD LEGACY PLUS PUMP
Report
- Report Number
- 3012307300-2021-08309
- Event Type
- Malfunction
- Date Received
- August 11, 2021
- Report Date
- March 1, 2022
- Manufacturer
- ST PAUL
- Product Code
- FRN
- UDI-DI
- 10610586019647
- PMA / PMN Number
- K982836
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
OTHER, OTHER TEXT: CUSTOMER REPORTED THAT DEVICE WAS SHOWING NO DISPOSABLE ALARM. TAMPER SEALS WERE ALL INTACT, LOOSE UPPER BACK LABEL. CUSTOMER PROBLEM WAS NOT DUPLICATED. PERFORMED VISUAL INSPECTION OF THE PUMP, AND NDA TESTING. UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM. REPLACED DOWNSTREAM SENSOR AS A PREVENTIVE MEASURE.
OTHER, OTHER TEXT: CUSTOMER REPORTED THAT DEVICE WAS SHOWING NO DISPOSABLE ALARM. TAMPER SEALS WERE ALL INTACT, LOOSE UPPER BACK LABEL. CUSTOMER PROBLEM WAS NOT DUPLICATED. PERFORMED VISUAL INSPECTION OF THE PUMP, AND NDA TESTING. UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM. REPLACED DOWNSTREAM SENSOR AS A PREVENTIVE MEASURE.
IT WAS REPORTED THAT DEVICE WAS SHOWING NO DISPOSABLE ALARM. NO PATIENT INJURY WAS REPORTED.
IT WAS REPORTED THAT DEVICE WAS SHOWING NO DISPOSABLE ALARM. NO PATIENT INJURY WAS REPORTED.
INFORMATION WAS RECEIVED INDICATING THAT DURING TESTING OF THIS SMITHS MEDICAL CADD LEGACY PLUS PUMP, THE PUMP EXHIBITED NO DISPOSABLE ALARM. NO PATIENT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1206816 | CADD LEGACY PLUS PUMP | PUMP, INFUSION | FRN | ST PAUL | 6500 | 10610586019647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |