ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-34701
- Event Type
- Malfunction
- Date Received
- August 28, 2024
- Date of Event
- August 5, 2024
- Report Date
- August 30, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- MEA
- UDI-DI
- 10885403812002
- PMA / PMN Number
- K043299
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.
CORRECTION: UNIQUE DEVICE IDENTIFIER (UDI)#, ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD, ANNEX B: B21, ANNEX C: C21, ANNEX D: D16. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER?, ANNEX B: B01, ANNEX C: C19, ANNEX D: D14. ROOT CAUSE: BASED ON THE FINDINGS, SERVICE WAS UNABLE TO DETERMINE THE PROBABLE CAUSE OF THE REPORTED ISSUE. THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING.
IT WAS REPORTED THAT THE DEVICE HAD COMM ERROR 9-100-1318. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE HAD COMM ERROR 9-100-1318. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180669 | ALARIS SYSTEM | PUMP, INFUSION | MEA | CAREFUSION SD | 8120 | 10885403812002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |