ALARIS SYSTEM
Report
- Report Number
- 2016493-2023-253148
- Event Type
- Malfunction
- Date Received
- January 8, 2024
- Date of Event
- December 5, 2023
- Report Date
- March 11, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403516023
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. 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. H3 OTHER TEXT : DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.
CORRECTION: IT WAS DETERMINED THROUGH INVESTIGATION OF THE DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2023-253148 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2023-253140 AND 2016493-2023-252587, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.
IT WAS REPORTED THAT THE DEVICES HAD SHUT DOWN DURING INFUSION THERE WAS PATIENT INVOLVEMENT, BUT OUTCOME IS UNKNOWN.
IT WAS REPORTED THAT THE DEVICES HAD SHUT DOWN DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, BUT OUTCOME IS UNKNOWN. CUSTOMER STATED NO DEVICES WILL BE SENT IN FOR INVESTIGATION HOWEVER WOULD LIKE LOGS INTERPRETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568620 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 | 10885403516023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |