ALARIS SYSTEM
Report
- Report Number
- 2016493-2021-69780
- Event Type
- Malfunction
- Date Received
- November 9, 2021
- Date of Event
- October 20, 2021
- Report Date
- November 10, 2021
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE RETURN TO MANUF .?, DEVICE EVAL BY MANUFACTURER?, IMDRF A, G, B, C & D CODES, MANUFACTURER NARRATIVE OMIT: IMDRF CODES: A1601 - DEVICE ALARM SYSTEM (1012), G0600101 - ALARM, AUDIBLE, B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE 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.
IT WAS REPORTED THAT THE DEVICE WAS SHOWING ALARM ERROR CODES / MESSAGES AND IT HAD MULTIPLE CHANNEL DISPLAY FAILURE ERRORS 211, 232. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE WAS SHOWING ALARM ERROR CODES / MESSAGES AND IT HAD MULTIPLE CHANNEL DISPLAY FAILURE ERRORS 211, 232. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1680287 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |