BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11128946 · Received January 6, 2021

    Report

    Report Number
    2016493-2021-02647
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Report Date
    December 21, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED PROBLEM WAS UNCONFIRMED. THE DEVICE WAS REPAIRED, RETESTED AND RETURNED TO THE CUSTOMER. 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. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT

    Description of Event or Problem · 1

    IUI- CORROSION. DAMAGED/CRACKED AIL SENSOR ASSY. LVP BEZEL POST RECALL GROUP 1 -DOM 2019- 12/21/2018 10:36:25 JEANNETTE KENEFICK (JKENEFIC) CONTACT: JOHN ELMORE - LEAD BIOMED 480-854-5417 [email protected] 12/12/2019 12:13:40 KIMBERLY JOHNSON (KIJOHNSO) UPDATE TO THE NOTE ABOVE FOR REPAIRS CONTACT BIOMED/NEAL GILBERT/(480)394-4046/ [email protected] 01/07/2020 12:09:59 NGOC T BUI (NBUI) EST - RCL TO MJR 01/16/2020 06:57:38 LAURYNE WASAN (LWASAN) NPI CONFIRMED UPDATED FROM RCL TO MJR FOR THE MAJOR REPAIRS NEEDED PER NGOC BUI, SERVICE TECH. REPAIR APPROVED BY NEAL GILBERT, BIOMED, AT NEAL.GI [email protected] FOR $230. USE NEW PO#152625-0-101 01/16/2020 06:59:54 LAURYNE WASAN (LWASAN) APPROVED FOR $365 01/21/2020 08:20:53 NGOC T BUI (NBUI) LVP BEZEL POST RECALL COMPLETED. REPLACED BEZEL ASSY (THIRD PARTY), AND BROKEN AIL SENSOR RIGHT SIDE. REPLACED CORRODED RIGHT,LEFT IUI. 01/21/2020 13:04:24 ANNETTE A MENDEZ (AMENDEZ) 1001891743160008514000142189307065 03/05/2020 07:50:04 JOSEPH KUHLS (JKUHLS) DURING THE REPAIR PROCESS, IT WAS DETERMINED THAT THE ORIGINAL PROBLEM CODE SHOULD HAVE BEEN BROK (BROKEN DAMAGED) FOR COMPLAINT TRENDING PURPOSES FILE REOPENED TO ADD TRACK WISE PR NUMBER TO THE DEVICE DATA FIELD. THIS FILE WAS INITIALLY CLASSIFIED AS A LEVEL 3 NON-COMPLAINT FOR PREVENTATIVE MAINTENANCE, UPGRADE, RECONDITIONING, CUSTOMER INQUIRY, OR RECALL WHICH DO NOT REQUIRE CUSTOMER ADVOCACY QUALITY REVIEW OR A NO PATIENT INVOLVED STATEMENT. THIS FILE CONTAINED DOCUMENTATION OF PRODUCT DEFICIENCY ALLEGATIONS, AND/OR REPAIRS (WHICH MAY OR MAY NOT HAVE BEEN PERFORMED) THAT ARE OUT-OF-SCOPE WITH THE INITIAL LEVEL 3 NON-COMPLAINT. SUCH DOCUMENTATION UPGRADED THE FILE TO A LEVEL 2 COMPLAINT, WHICH REQUIRED A LEVEL 2 CUSTOMER ADVOCACY QUALITY REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19049 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1