BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11084751 · Received December 28, 2020

    Report

    Report Number
    2016493-2020-82226
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Report Date
    October 15, 2019
    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 CONFIRMED. 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 TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    LVP BEZEL POST RECALL GROUP 2 -DOM 2019- 10/15/2019 08:41:16 JOVELYN MARTIN (JOBMARTI) CONTACT KEVIN DUBOSE BIOMED #404-785-5190/4895 <[email protected]> 10/25/2019 15:10:56 DIANE H NGUYEN (DHNGUYEN) MISSED - EST - RCL TO MNR. 11/21/2019 08:27:36 LAURYNE WASAN (LWASAN) NPI CONFIRMED UPDATED FROM RCL TO MNR FOR THE MINOR REPAIRS NEEDED PER DIANE NGUYEN, SERVICE TECH. REPAIR APPROVED BY KEVIN DUBOSE, BIOMED, AT KEV [email protected] FOR $230. USE NEW PO# 1666722 11/26/2019 14:24:46 DIANE H NGUYEN (DHNGUYEN) LVP BEZEL POST RECALL COMPLETED. REPLACED BEZEL, DOOR, REAR CASE, IUI CONNECTORS, AND SEAR. PERFORMED PM, AND CALIBRATION. 11/26/2019 19:26:49 DIANE H NGUYEN (DHNGUYEN) REPLACED U4 ON DISPLAY BOARD FOR DIM SEGMENT. 11/26/2019 19:27:32 JORGE SANCHEZ (JORGSANC) VERIFIED U4 PASSED SOLDER PCB 11/27/2019 05:38:14 CHRISTINA CASTANEDA (CHCASTAN) 1001910524070003034200132721490211 12/11/2019 09:00:56 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
    1549165 8100 ALARIS PUMP MODULE PUMP,INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1