ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-47081
- Event Type
- Malfunction
- Date Received
- January 13, 2025
- Date of Event
- December 18, 2024
- Report Date
- January 22, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- 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 INFORMATION: MANUFACTURER NARRATIVE. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE OF AN NUISANCE ALARMS WAS NOT DETERMINED BECAUSE NO PRODUCTS OR DEVICE LOGS WERE RETURNED.
THE ACTUAL DATE OF EVENT IS UNKNOWN. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.
IT WAS REPORTED THROUGH NPS SURVEY THAT DEVICES CAN BE HARD TO PROGRAM DRIP RATES BECAUSE THE DEVICE BEEPS "INCESSANTLY" WITHOUT A CLEAR INDICATION OF WHAT IS WRONG MOST THE TIME. THERE WAS NO INFORMATION ON PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.
IT WAS REPORTED THROUGH NPS SURVEY THAT DEVICES CAN BE HARD TO PROGRAM DRIP RATES BECAUSE THE DEVICE BEEPS "INCESSANTLY" WITHOUT A CLEAR INDICATION OF WHAT IS WRONG MOST THE TIME. THERE WAS NO INFORMATION ON PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 516500 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015. |