FDA Adverse Event
Malfunction
Summary report: N
ALARIS SYSTEM
MDR report key: 12647136
·
Received October 18, 2021
Report
- Report Number
- 2016493-2021-65251
- Event Type
- Malfunction
- Date Received
- October 18, 2021
- Date of Event
- September 28, 2021
- Report Date
- November 5, 2021
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
OMIT :A090103 - NO AUDIBLE PROMPT / FEEDBACK (2282), 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.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE FAILED TO ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative · 1
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 · 1
IT WAS REPORTED THAT THE DEVICE FAILED TO ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1544097 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |