BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 10783719 · Received November 4, 2020

    Report

    Report Number
    2016493-2020-32552
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Report Date
    March 21, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K091308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS-USED INFORMATION WERE REVIEWED FOR THE SAP AND TRACK WISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE SOURCE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. CAPA REFERENCE: (B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). AFTER INVESTIGATION, THE DEVICE MODULE RUN TIME WAS CREATED BY COMPANY EMPLOYEES. THIS DEVICE MEETS THE CRITERIA PER (B)(4) OUT-OF-BOX FAILURE PROCESSING DOCUMENT # (B)(4) FOR RESTOCKING BACK TO FINISHED GOODS WAREHOUSE. (B)(4). INVESTIGATION SUMMARY: REPORTED 'TAMPER SWITCH INOP' DURING THE DEVICE CHECK IN WAS CONFIRMED. AS RECEIVED, THE TAMPER SWITCH IS CONFIRMED FAILING DURING THE KEYPAD TESTING. THE SIO BOARD ASSEMBLY WAS REMOVED FOR VISUAL INSPECTION OF THE TAMPER SWITCH ASSEMBLY. NO ANOMALIES' OBSERVED, THE TAMPER SWITCH HARNESS WERE PROPERLY SOLDERED AND THE SWITCH IS BOUNCING PROPERLY. FAILURE INVESTIGATION WAS ABLE TO REPRODUCE REPORT 'TAMPER SWITCH FAILED KEYPAD TEST' TO THE FASTENING OF THE SIO BOARD. CONCLUSION: FAILURE INVESTIGATION WAS ABLE TO REPRODUCE REPORT 'TAMPER SWITCH FAILED KEYPAD TEST' TO THE FASTENING OF THE SIO BOARD. FOR BETTER RESULT, IT RECOMMENDING TIGHTENED A SCREW IN CROSS PATTERN. REWORK: RE-INSTALLED SIO BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251227 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1