BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 20629054 · Received November 7, 2024

    Report

    Report Number
    2016493-2024-40662
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    April 16, 2024
    Report Date
    November 27, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403516023
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 FAULTY TAMPER SWITCH WAS CONFIRMED. ¿ ON 22-JUL-2024, PCU WAS RECEIVED UNBOXED AND WITH PAPERWORK. ¿ PCU WHEN ATTACHED TO LAB PASSED ASM FUNCTIONAL TESTING. ¿ INTERNAL INVESTIGATION WAS NOT DEEMED NECESSARY. ¿ DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR PROCESSING. ¿ RECOMMEND BD SAN DIEGO REPAIR CENTER REPLACE SIO BOARD WITH NEW FUNCTIONAL SIO BOARD. ¿ 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.

    Additional Manufacturer Narrative · 0

    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 FAULTY TAMPER SWITCH WAS CONFIRMED. ON (B)(6) 2024, PCU WAS RECEIVED UNBOXED AND WITH PAPERWORK. PCU WHEN ATTACHED TO LAB PASSED ASM FUNCTIONAL TESTING. INTERNAL INVESTIGATION WAS NOT DEEMED NECESSARY. DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR PROCESSING. RECOMMEND BD SAN DIEGO REPAIR CENTER REPLACE SIO BOARD WITH NEW FUNCTIONAL SIO BOARD. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD FAULTY TAMPER SWITCH. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD FAULTY TAMPER SWITCH. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50052 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403516023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown