ALARIS SYSTEM
Report
- Report Number
- 2016493-2025-140758
- Event Type
- Malfunction
- Date Received
- December 5, 2025
- Date of Event
- November 18, 2025
- Report Date
- December 26, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403519284
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DISREGARD THE INITIAL REPORT MFR REPORT #2016493-2025-140758.AFTER FURTHER REVIEW OF THE FILE IT WAS DETERMINED THAT THIS FILE IS NOT A REPORTABLE COMPLAINT AND THE MDR WAS SUBMITTED IN ERROR.
CORRECTION : MANUFACTURER NARRATIVE A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING 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.
A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING. 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.
IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED FOR THE REPORTED FAILURE AS IT WAS OBSERVED BY THE MANUFACTURER DURING SERVICING ACTIVITY.
IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED FOR THE REPORTED FAILURE AS IT WAS OBSERVED BY THE MANUFACTURER DURING SERVICING ACTIVITY.
IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED FOR THE REPORTED FAILURE AS IT WAS OBSERVED BY THE MANUFACTURER DURING SERVICING ACTIVITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2846834 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 | 10885403519284 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |