BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 20046766 · Received August 23, 2024

    Report

    Report Number
    2016493-2024-34510
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    August 2, 2024
    Report Date
    September 26, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 QR CODE ON PUMP FACE OUT OF BOX WAS CONFIRMED. ON 29-AUG-2024, LVP WAS RECEIVED UNBOXED AND WITH PAPERWORK. LVP WHEN ATTACHED TO LAB PASSES ASM FUNCTIONAL TESTING. VISUAL INSPECTION HAS CONFIRMED QR CODE ON PUMP FACE. DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR PROCESSING. RECOMMEND BD SAN DIEGO REPAIR CENTER TO REMOVE THE QR CODE ON PUMP FACE. ONCE COMPLETED, THIS DOCUMENT IS CONSIDERED A RECORD THAT MUST BE STORED IN ACCORDANCE WITH COMPANY PROCEDURES. FOR INTERNAL USE ONLY. THIS DOCUMENT CONTAINS CONFIDENTIAL, PROPRIETARY INFORMATION OF BD OR ONE OF ITS AFFILIATES. IT MAY NOT BE COPIED OR REPRODUCED WITHOUT PRIOR WRITTEN PERMISSION FROM BD. PAGE 4 OF 4 RECORD NUMBER 1503-001-001-R-CFN, DIR (B)(4), VERSION 07 RELEASE DATE: 25JUL2024 DOCO USE ONLY (APPROVER¿S LIST): 0204-001-001-REC-CFN (LATEST VERSION) TO DETERMINE AUTHORIZED APPROVERS DOCO USE ONLY (RECORD FORMAT TEMPLATE) 0204-011-005-R-CFN, DIR 10000153640, VER 04, RELEASE DATE: 21OCT2021. 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD QR CODE ON PUMP FACE OUT OF BOX. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD QR CODE ON PUMP FACE OUT OF BOX. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256971 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown