ALARIS SYSTEM
Report
- Report Number
- 2016493-2023-104764
- Event Type
- Injury
- Date Received
- January 30, 2023
- Date of Event
- January 6, 2023
- Report Date
- February 2, 2023
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- PMA / PMN Number
- K133532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
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. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.
ADDITIONAL INFORMATION: IMDRF ANNEX A AND G CODES.
IT WAS REPORTED THAT PUMP "STOPPING INFUSION AND RESTARTING ON ITS OWN." THE MEDICATION ADMINISTRATION RECORD (MAR) IS INDICATING THAT THE PUMP HAS STOPPED INFUSION AND RESTARTED. THE PATIENT HAS SHOWN DETERIORATION ON THE PUMPS THAT REFLECTED THIS BEHAVIOR. THERE WAS UNSPECIFIED PATIENT INJURY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.
IT WAS REPORTED THAT PUMP "STOPPING INFUSION AND RESTARTING ON ITS OWN." THE MEDICATION ADMINISTRATION RECORD (MAR) IS INDICATING THAT THE PUMP HAS STOPPED INFUSION AND RESTARTED. THE PATIENT HAS SHOWN DETERIORATION ON THE PUMPS THAT REFLECTED THIS BEHAVIOR. THERE WAS UNSPECIFIED PATIENT INJURY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5948 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | 8015 |