ALARIS SYSTEM
Report
- Report Number
- 2016493-2022-152215
- Event Type
- Malfunction
- Date Received
- June 10, 2022
- Date of Event
- May 19, 2022
- Report Date
- June 17, 2022
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Removal / Correction Number
- Z-2822-2020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 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.
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.
IT WAS REPORTED THAT THE DEVICE HAD MISSING DIGITS ON DISPLAY DURING TEST. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE HAD MISSING DIGITS ON DISPLAY DURING TEST. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 630307 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |