BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 19664778 · Received July 3, 2024

    Report

    Report Number
    2016493-2024-30749
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 10, 2024
    Report Date
    January 6, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    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 STICKING DOOR LATCH WAS CONFIRMED. ON 12-AUG-2024, LVP WAS RECEIVED UNBOXED AND WITH PAPERWORK. LVP WHEN ATTACHED TO LAB PCU PASSES ASM FUNCTIONAL TESTING. THE LATCH SCREW WAS OVER TORQUED SCREWS WAS MAKING LATCH DOOR STUCK. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: ANNEX B: B21 ANNEX C: C21 ANNEX D: D16 UNIQUE DEVICE IDENTIFIER (UDI)#, ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL? RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER? ANNEX A: A1502 ANNEX B: B01 ANNEX C: C07 ANNEX D: D02 ANNEX G: G0405206 INVESTIGATION SUMMARY: FIELD TECHNICIAN STATED ISSUE OF STICKING DOOR LATCH WAS CONFIRMED. ON (B)(6) 2024, LVP WAS RECEIVED UNBOXED AND WITH PAPERWORK. LVP WHEN ATTACHED TO LAB PCU PASSES ASM FUNCTIONAL TESTING. THE LATCH SCREW WAS OVER TORQUED SCREWS WAS MAKING LATCH DOOR STUCK. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD STICKING DOOR LATCH. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD STICKING DOOR LATCH. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD STICKING DOOR LATCH. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508047 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown