ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-31158
- Event Type
- Malfunction
- Date Received
- July 5, 2024
- Date of Event
- June 14, 2024
- Report Date
- January 28, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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. 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.
CORRECTION: ANNEX A: A1102 AND ANNEX G: G0200802. ADDITIONAL INFORMATION: ANNEX A: A1601 AND ANNEX G: G0600101. A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. INVESTIGATION SUMMARY: FIELD TECHNICIAN STATED ISSUE OF ¿CHANNEL ERROR 13-1064-1257" WAS CONFIRMED. UPON POWER UP DEVICE ALARMED WITH ERROR CODE 13-1064-1257. SOFTWARE VERSION 12.1.2.78 WAS REINSTALLED TO LVP DEVICE. ERROR CODE WAS NO LONGER OBSERVED UPON POWER UP. NOTED ISSUE WAS CORRECTED IN BD SAN DIEGO OPERATION'S LAB. NO REPAIR REQUIRED BY BD SAN DIEGO REPAIR CENTER. "ON 09-DEC-2024, LVP DEVICE WAS RECEIVED UNBOXED AND WITH PAPERWORK. EXTERNAL INVESTIGATION CONFIRMED THE REPORTED PROBLEM UPON POWER UP. DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR NORMAL PROCESSING. NOTED ISSUE WAS CORRECTED IN BD SAN DIEGO OPERATION¿S LAB. NO REPAIR REQUIRED BY BD SAN DIEGO REPAIR CENTER. 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.
A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. FIELD TECHNICIAN STATED ISSUE OF ¿CHANNEL ERROR 13-1064-1257 WAS CONFIRMED. UPON POWER UP DEVICE ALARMED WITH ERROR CODE 13-1064-1257. SOFTWARE VERSION 12.1.2.78 WAS REINSTALLED TO LVP DEVICE. ERROR CODE WAS NO LONGER OBSERVED UPON POWER UP. NOTED ISSUE WAS CORRECTED IN BD SAN DIEGO OPERATION'S LAB. NO REPAIR REQUIRED BY BD SAN DIEGO REPAIR CENTER. ON 09-DEC-2024, LVP DEVICE WAS RECEIVED UNBOXED AND WITH PAPERWORK. ¿ EXTERNAL INVESTIGATION CONFIRMED THE REPORTED PROBLEM UPON POWER UP. ¿ DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR NORMAL PROCESSING. ¿ NOTED ISSUE WAS CORRECTED IN BD SAN DIEGO OPERATION¿S LAB. NO REPAIR REQUIRED BY BD SAN DIEGO REPAIR CENTER. THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING. 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.
IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 13-1064-1257. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 13-1064-1257. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 13-1064-1257. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 477658 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |