BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11300373 · Received February 9, 2021

    Report

    Report Number
    2016493-2021-23375
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Report Date
    August 9, 2016
    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 · 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 NOT BEEN PREVIOUSLY RETURNED FOR SERVICE. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE SOURCE DEVICE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT. 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.

    Description of Event or Problem · 1

    08/09/2016 18:32:43 WILLIAM BURDETTE (WBURDETT) FOR ADDITIONAL REPAIRS PLEASE CONTACT SHANE MAGEE, BIOMED [email protected], 718-470-7000 X 60024 08/24/2016 07:44:40 GABRIEL LOPES (GLOPES) STATION 45 TOOLS USED EQ 103106 EQ 102890 EQ 102782 UNIT RECEIVED WITH: REAR CASE CRACKED BOTTOM LEFT REAR SCREW MOUNT, IUIS CORRODED, HANDLE CRACKED, LATCH ASSEMBLY CRACKED. 01/06/2017 07:25:52 JESSICA GALANG (JGALANG) UPDATED FROM RCL TO MNR FOR THE MINOR REPAIR NEEDED PER GABRIEL LOPES, SERVICE TECH. REPAIR APPROVED BY WILHELM SEDLER, BIOMED DIRECTOR, AT [email protected] FOR $159.30 (55% DISCOUNT APPROVED BY BARBARA WILHITE, BD SERVICE CONTRACTS). NEW PO# IS 1716660696. NPI HAS BEEN CONFIRMED BY HARRY GOLDSMITH, BD SALES REP, AT [email protected] WITH THE CUSTOMER. 01/09/2017 14:20:44 JONATHAN REYES (JOREYES) 1Z9791540267921023 01/19/2018 08:24:55 JOSEPH KUHLS (JKUHLS) 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
    200579 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1