BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 10558689 · Received September 21, 2020

    Report

    Report Number
    2016493-2020-09849
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Report Date
    March 3, 2017
    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 PRESENT DATE. THIS DEVICE WAS PREVIOUSLY RETURNED FOR SERVICE. 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 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 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)(6) 2017 09:47:31 (B)(6). SCAP-UNIT WAS REMEDIATED AND WHEN TESTED BY REMEDIATION FIELD TECH UNIT EXHIBITED ERROR 133.6080. CHARGE TO RECALL # 911165 PER (B)(6). (B)(6) 2017 09:08:15 (B)(6). SOLDER PADS WERE DAMAGED DURING ON-THE-FIELD REMEDIATION. (B)(6) 2017 14:38:45 (B)(6). (B)(4). (B)(6) 2018 08:40:01 (B)(6). FILE REOPENED TO ADD TRACK WISE PR NUMBER TO THE DEVICE DATA FIELD. THIS FILE MAY OR MAY NOT CONTAIN NPI BECAUSE IT WAS INITIALLY CREATED AS A PM / UPGRADE OR RECALL FILE, WHICH DOES NOT REQUIRE THE NPI, AND LATER CONVERTED TO A MAJOR/MINOR REPAIR IN ORDER TO PERFORM THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027132 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1