ALARIS SYSTEM
Report
- Report Number
- 2016493-2025-62896
- Event Type
- Malfunction
- Date Received
- February 21, 2025
- Date of Event
- January 27, 2025
- Report Date
- April 16, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810046
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
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 REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.
ADDITIONAL INFORMATION: IMDRF ANNEX B CODE AND 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. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE OF AN ERROR 13-1033-149 WAS NOT DETERMINED BECAUSE NO PRODUCTS OR DEVICE LOGS WERE RETURNED.
IT WAS REPORTED THAT THE PUMP ALARMED AND DISPLAYED ERROR 13-1033-149. THERE WAS NO INFORMATION ON PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE PUMP ALARMED AND DISPLAYED ERROR 13-1033-149. THERE WAS NO INFORMATION ON PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1045010 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |