ALARIS SYSTEM
Report
- Report Number
- 2016493-2023-252423
- Event Type
- Malfunction
- Date Received
- December 29, 2023
- Date of Event
- October 19, 2023
- Report Date
- March 11, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403801518
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 505
Narratives
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 RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2023-252423 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2023-246195, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.
IT WAS REPORTED THAT DEXTROSE 5% IN WATER (D5W) BAG RAN DRY, AND THE AIR IN THE TUBING WENT PAST THE AIR-IN-LINE SENSOR. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT DEXTROSE 5% IN WATER (D5W) BAG RAN DRY, AND THE AIR IN THE TUBING WENT PAST THE AIR-IN-LINE SENSOR. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2245411 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 | 10885403801518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |