FDA Adverse Event
Malfunction
Summary report: N
ALARIS SYSTEM
MDR report key: 15722293
·
Received November 3, 2022
Report
- Report Number
- 2016493-2022-217711
- Event Type
- Malfunction
- Date Received
- November 3, 2022
- Date of Event
- September 29, 2022
- Report Date
- November 7, 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
- SD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: REMEDIAL ACTION REQUIRED, REMEDIAL ACTION # ANNEX A: A090202. ANNEX G: G05005. ANNEX C: C16. ANNEX D: D03.
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 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.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE DOOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE DOOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2799328 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |