ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-38812
- Event Type
- Malfunction
- Date Received
- October 11, 2024
- Date of Event
- September 19, 2024
- Report Date
- April 16, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810046
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- 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 WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.
ANNEX B: B21. ANNEX C: C21. ANNEX D: D16 ANNEX B: B01. ANNEX C: C10. ANNEX D: D15. 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 THIS MDR REPORT. INVESTIGATION SUMMARY: FIELD TECHNICIAN STATED ISSUE OF ERROR 13-1064-1229 WAS CONFIRMED. ON 25-NOV-2024, 9 LVP DEVICES WERE RECEIVED UNBOXED AND WITH PAPERWORK. THE 9 LVP UNITS POWERED ON WITH ERROR CODE 13-1064-1229 DUE TO CORRUPT OR MISSING SOFTWARE. UNITS WERE RE-FLASHED. ALL 9 LVPS FUNCTIONED NORMALLY WITH NO ERRORS AFTER, THEN TESTED ALONG WITH A PCU AND ASFT CHECK-IN TESTING, NO OTHER ISSUES NOTED. DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR PROCESSING. AS A PRECAUTION, RECOMMEND BD SAN DIEGO REPAIR CENTER REPLACE THE LOGIC BOARDS. FAILURE INVESTIGATION REPORT ATTACHED TO QN IN SAP. 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 ERROR 13-1064-1229 WAS CONFIRMED. ON 25-NOV-2024, 9 LVP DEVICES WERE RECEIVED UNBOXED AND WITH PAPERWORK. THE 9 LVP UNITS POWERED ON WITH ERROR CODE 13-1064-1229 DUE TO CORRUPT OR MISSING SOFTWARE. UNITS WERE RE-FLASHED. ALL 9 LVPS FUNCTIONED NORMALLY WITH NO ERRORS AFTER, THEN TESTED ALONG WITH A PCU AND ASFT CHECK-IN TESTING, NO OTHER ISSUES NOTED. DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR PROCESSING. AS A PRECAUTION, RECOMMEND BD SAN DIEGO REPAIR CENTER REPLACE THE LOGIC BOARDS. FAILURE INVESTIGATION REPORT ATTACHED TO QN IN SAP. 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.
CORRECTION: ANNEX C: C10 ANNEX D: D15 ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER?, ANNEX A: A0721 ANNEX C: C16 ANNEX D: D03 ANNEX G: G02005
IT WAS REPORTED THAT THE DEVICE DISPLAYED AN ERROR CODE 13-1064-1229. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE DISPLAYED AN ERROR CODE 13-1064-1229. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE DISPLAYED AN ERROR CODE 13-1064-1229. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE DISPLAYED AN ERROR CODE 13-1064-1229. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341898 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |