BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11137159 · Received January 7, 2021

    Report

    Report Number
    2016493-2021-03431
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Report Date
    July 25, 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. THE DEVICE WAS REPAIRED, RETESTED, AND RETURNED TO THE CUSTOMER. BASED ON THE FILE REVIEW, NO FURTHER ESCALATION IS REQUIRED PER 1501-006-000 SWI-SD-INF COMPLAINTS ESCALATION, INFUSION PRODUCTS GLOBAL CUSTOMER SUPPORT OPERATIONS. 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- 07/25/2019 09:24:52 MONICA A BENNETT (MABENNET) FOR RECALL CONTACT JAMES HACKLER SITE LEAD DCS 941-475-6571 EXT 3772 EMAIL:[email protected] 08/07/2019 12:18:54 THONG TRANG (TTRANG) ESTIMATE MJR WAITING FOR APPROVAL. 08/29/2019 07:56:07 LAURYNE WASAN (LWASAN) NPI CONFIRMED UPDATED FROM RCL TO MJR FOR THE MAJOR REPAIRS NEEDED PER THONG TRANG, SERVICE TECH. REPAIR APPROVED BY STACIE VANNOSTRAND, BIOMED, AT [email protected] FOR $365. USE NEW PO# 106329 09/11/2019 09:18:09 THONG TRANG (TTRANG) LVP BEZEL POST RECALL COMPLETED, REPLACED BEZEL ASSEMBLY. 09/12/2019 06:39:41 ANNETTE A MENDEZ (AMENDEZ) 1001901781840003422300119242560105 01/31/2020 12:56:06 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
    29725 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1