FDA Adverse Event
Malfunction
Summary report: N
ALARIS SYSTEM
MDR report key: 18325209
·
Received December 14, 2023
Report
- Report Number
- 2016493-2023-249576
- Event Type
- Malfunction
- Date Received
- December 14, 2023
- Date of Event
- November 22, 2023
- Report Date
- December 15, 2023
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810046
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.
Additional Manufacturer Narrative · 0
ANNEX B: B21; ANNEX C: C21; ANNEX D: D16. ANNEX A: A070908; ANNEX B: B01; ANNEX C: C070606 ; ANNEX D: D02; ANNEX G: G03005.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE HAD DISPLAYED AN ERROR CODE 242.4030. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE HAD DISPLAYED AN ERROR CODE 242.4030. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1781025 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |