ALARIS SYSTEM
Report
- Report Number
- 2016493-2023-161608
- Event Type
- Malfunction
- Date Received
- May 12, 2023
- Date of Event
- April 13, 2023
- Report Date
- August 29, 2023
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810046
- PMA / PMN Number
- K133532
- Removal / Correction Number
- Z-2736-2020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CORRECTION: ANNEX A: A040101. ANNEX G: G04088. ADDITIONAL INFORMATION: ANNEX A: A0401. ANNEX G: G04036.
ADDITIONAL INFORMATION : ANNEX C : C23. ANNEX D : D11.
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. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE
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.
IT WAS REPORTED THAT THE DEVICE HAD HIGH ACCURACY IN VOLUME, TEMPERATURE AND PRESSURE. THERE WAS PATIENT INVOLVEMENT BUT IMPACT WAS UNKNOWN.
IT WAS REPORTED THAT THE DEVICE HAD HIGH ACCURACY IN VOLUME, TEMPERATURE AND PRESSURE. THERE WAS PATIENT INVOLVEMENT BUT IMPACT WAS UNKNOWN.
IT WAS REPORTED THAT THE DEVICE HAD HIGH ACCURACY IN VOLUME, TEMPERATURE AND PRESSURE. THERE WAS PATIENT INVOLVEMENT BUT IMPACT WAS UNKNOWN.
IT WAS REPORTED THAT THE DEVICE HAD HIGH ACCURACY IN VOLUME, TEMPERATURE AND PRESSURE. THERE WAS PATIENT INVOLVEMENT BUT IMPACT WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1031088 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | 8015. |