ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-45678
- Event Type
- Malfunction
- Date Received
- December 27, 2024
- Date of Event
- December 6, 2024
- Report Date
- March 24, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 ¿DISPLAY ¿ BLANK SCREEN¿ WAS CONFIRMED. ¿ RECEIVED ON 27-JAN-2025 INTO BD SAN DIEGO OPERATION¿S LAB. LVP UNIT WAS RECEIVED UNBOXED AND WITH PAPERWORK. ¿ IMPROPERLY SEATED DOOR HARNESS CONNECTOR. WORKMANSHIP AT BD MANUFACTURING ¿ DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR PROCESSING. ¿ NOTED ISSUE(S) WERE CORRECTED IN BD SAN DIEGO OPERATION¿S LAB. NO REPAIR REQUIRED BY BD SAN DIEGO REPAIR CENTER. ¿ 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.
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 ¿DISPLAY ¿ BLANK SCREEN¿ WAS CONFIRMED. RECEIVED ON 27-JAN-2025 INTO BD SAN DIEGO OPERATION¿S LAB. LVP UNIT WAS RECEIVED UNBOXED AND WITH PAPERWORK. IMPROPERLY SEATED DOOR HARNESS CONNECTOR. WORKMANSHIP AT BD MANUFACTURING. DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR PROCESSING. NOTED ISSUE(S) WERE CORRECTED IN BD SAN DIEGO OPERATION¿S LAB. NO REPAIR REQUIRED BY BD SAN DIEGO REPAIR CENTER. 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.
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.
IT WAS REPORTED THAT THE DEVICE HAD BLANK DISPLAY SCREEN. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE HAD BLANK DISPLAY SCREEN. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE HAD BLANK DISPLAY SCREEN. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2512803 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |