BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 12208216 · Received July 22, 2021

    Report

    Report Number
    2016493-2021-509949
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Report Date
    January 15, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    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. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE SOURCE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 25JUN2014. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN BD2 TRACKWISE WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    (B)(6) 2018 06:11:17 (B)(6). NPI- REPLACED BATTERY. (B)(6) 2018 06:38:16 (B)(6). REPLACED BATTER EQ 103615 EQ09116. THERE WAS NO PATIENT INVOLVEMENT.

    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. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE SOURCE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 25JUN2014. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. 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 WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(4) WAS PERFORMED IN BD2 TRACKWISE WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    NPI- REPLACED BATTERY. REPLACED BATTER EQ, 103615, EQ09116. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105315 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown