FDA Adverse Event
Malfunction
Summary report: N
ALARIS SYSTEM
MDR report key: 23036753
·
Received September 12, 2025
Report
- Report Number
- 2016493-2025-113440
- Event Type
- Malfunction
- Date Received
- September 12, 2025
- Date of Event
- August 22, 2025
- Report Date
- September 24, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. 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.
Additional Manufacturer Narrative · 0
UPON FURTHER EVALUATION OF THE COMPLAINT RECORD IT WAS CONFIRMED THAT THERE WERE NO DEVICE MALFUNCTION OR FAILURE. THE REPORT WAS SUBMITTED IN ERROR, PLEASE DISREGARD THE INITIAL REPORT WITH MFR REPORT 2016493-2025-113440.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 353.6650. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 353.6650. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2675418 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |