FDA Adverse Event
Malfunction
Summary report: N
ALARIS SYSTEM
MDR report key: 15823878
·
Received November 18, 2022
Report
- Report Number
- 2016493-2022-228156
- Event Type
- Malfunction
- Date Received
- November 18, 2022
- Date of Event
- October 7, 2022
- Report Date
- December 9, 2022
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403211423
- PMA / PMN Number
- K133532
- Removal / Correction Number
- Z-2718-2020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 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.
Additional Manufacturer Narrative · 0
CORRECTION: ANNEX C: C070601. ADDITIONAL INFORMATION: ANNEX C: C0601.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN 8100 LVP WAS AFFECTED BY PLASTIC RECALL. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN 8100 LVP WAS AFFECTED BY PLASTIC RECALL. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228317 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403211423 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |