ALARIS SYSTEM
Report
- Report Number
- 2016493-2025-140841
- Event Type
- Malfunction
- Date Received
- December 5, 2025
- Date of Event
- November 14, 2025
- Report Date
- January 12, 2026
- 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
- BIOMEDICAL ENGINEER
- 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. INVESTIGATION SUMMARY: FIELD TECHNICIANS STATED ISSUE OF ¿IUI MALE (RIGHT) - COMMUNICATION ERROR *DEVICE DOES NOT POWER ON¿ WAS CONFIRMED. ¿ ON (B)(6) 2025, THE LVP DEVICE WAS RECEIVED UNBOXED AND WITH PAPERWORK. ¿ INTERNAL INSPECTION REVEALED MISALIGNMENT OF THE MOTOR CONTROL BOARD CAUSING THE COMMUNICATION FAILURE. ¿ DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR PROCESSING. ¿ NOTED ISSUE WAS CORRECTED IN BD SAN DIEGO OPERATION¿S LAB. NO REPAIR REQUIRED BY BD SAN DIEGO REPAIR CENTER. RECOMMEND BD SAN DIEGO REPAIR CENTER REPLACE THE NEW TAMPER SEAL. ¿ FAILURE INVESTIGATION REPORT ATTACHED TO SALESFORCE. 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. INVESTIGATION SUMMARY: FIELD TECHNICIANS STATED ISSUE OF ¿IUI MALE (RIGHT) - COMMUNICATION ERROR *DEVICE DOES NOT POWER ON¿ WAS CONFIRMED. - ON 25-NOV-2025, THE LVP DEVICE WAS RECEIVED UNBOXED AND WITH PAPERWORK. - INTERNAL INSPECTION REVEALED MISALIGNMENT OF THE MOTOR CONTROL BOARD CAUSING THE COMMUNICATION FAILURE. - DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR PROCESSING. - NOTED ISSUE WAS CORRECTED IN BD SAN DIEGO OPERATION¿S LAB. NO REPAIR REQUIRED BY BD SAN DIEGO REPAIR CENTER. RECOMMEND BD SAN DIEGO REPAIR CENTER REPLACE THE NEW TAMPER SEAL. - FAILURE INVESTIGATION REPORT ATTACHED TO SALESFORCE. 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 IUI MALE (RIGHT) - COMMUNICATION ERROR AND DEVICE DOES NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE HAD IUI MALE (RIGHT) - COMMUNICATION ERROR AND DEVICE DOES NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE HAD IUI MALE (RIGHT) - COMMUNICATION ERROR AND DEVICE DOES NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2844074 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |