BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11138456 · Received January 8, 2021

    Report

    Report Number
    2016493-2021-03541
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    August 9, 2019
    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

    THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. 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

    LVP BEZEL POST RECALL GROUP 1-DOM 2019- 08/09/2019 10:19:13 DWAYNE DAVIDS (DDAVIDS) BIOMED CONTACT RONALD BLOUNT 757-507-1250 OPT 2 [email protected] 08/21/2019 07:38:47 LIEN N TRAN (LTRAN) EST-RCL TO MJR 09/03/2019 12:43:18 CRISLEIVY PENA (CRPENA) NPI CONFIRMED UPDATED FROM RCL TO MJR FOR THE MAJOR REPAIR NEEDED PER LIEN N TRAN, SERVICE TECH. REPAIR APPROVED BY RONALD BLOUNT, BIOMED AT RONAL [email protected] FOR $365. NEW PO# TMXC0299664. 09/16/2019 11:29:49 ANNETTE A MENDEZ (AMENDEZ) 1001910582410002345600119242562759 01/31/2020 13:37:01 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
    39317 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1