BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10558565 · Received September 21, 2020

    Report

    Report Number
    2016493-2020-09679
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Report Date
    January 23, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORTED EVENT AND ANY SUBSEQUENT REPAIRS HAVE BEEN INVESTIGATED THROUGH THE NORMAL SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS USED INFORMATION, WAS REVIEWED FOR THE SAP FILE AND TRACK WISE FILE, AND FOUND TO BE RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE SOURCE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE AND INDICATED THAT THIS DEVICE HAS BEEN PREVIOUSLY RETURNED FOR SERVICE. SERVICE RETURNS WERE FOR UNRELATED ISSUES. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE SOURCE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN 9945000 WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE AND PRODUCT WAS RETURNED) FOR THE SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A CHR (COMPLAINT HISTORY RECORD) REVIEW IN THE TRACK WISE WAS PERFORMED FOR THE (B)(6) WHICH CONFIRMED THAT NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. CAPA REFERENCE : CA-2018-0171. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    FAILED PREVENTIVE MAINTENANCE. MOTOR CONTROL BOARD- CORROSION, DOOR ASSY- KEYPAD DAMAGED, BEZEL ASSY- LOWER HINGE CRACK, AIL SENSOR ASSY- CRACKED HOUSING AND CASE REAR- CORROSION. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND ANY SUBSEQUENT REPAIRS HAVE BEEN INVESTIGATED THROUGH THE NORMAL SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS USED INFORMATION, WAS REVIEWED FOR THE SAP FILE AND TRACK WISE FILE, AND FOUND TO BE RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE SOURCE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE AND INDICATED THAT THIS DEVICE HAS BEEN PREVIOUSLY RETURNED FOR SERVICE. SERVICE RETURNS WERE FOR UNRELATED ISSUES. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE SOURCE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE AND PRODUCT WAS RETURNED) FOR THE SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A CHR (COMPLAINT HISTORY RECORD) REVIEW IN THE TRACK WISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED THAT 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026191 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1