BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11045006 · Received December 21, 2020

    Report

    Report Number
    2016493-2020-75238
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Report Date
    August 22, 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. 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 RECALL-MAY HAVE AFFECTED BZL- 08/22/2019 09:14:01 SANDRA J MCDONALD (SMCDONAL) LVP BEZEL RECALL 2019 UNIT MAY CONTAIN AN AFFECTED BEZEL. JOSEPH NICHOLS, BIOMED 623-524-3087 [email protected] 08/22/2019 09:30:57 SANDRA J MCDONALD (SMCDONAL) EMAIL CORRECTION: [email protected] 08/29/2019 05:36:53 LIEN N TRAN (LTRAN) EST-RCL TO MNR 08/30/2019 11:45:13 SANDRA J MCDONALD (SMCDONAL) [email protected] 09/30/2019 09:59:25 LAURYNE WASAN (LWASAN) NPI CONFIRMED UPDATED FROM RCL TO MNR FOR THE MINOR REPAIRS NEEDED PER LIEN TRAN, SERVICE TECH. REPAIR APPROVED BY JOSEPH NICHOLS, BIOMED, AT JOS [email protected] FOR $230. USE NEW PO# 139548-0-101 09/30/2019 13:43:09 LIEN N TRAN (LTRAN) REPLACED U4 ON DISPLAY BOARD. 09/30/2019 13:47:29 ALLAN DULAY (ADULAY) VERIFIED U4 SOLDER ON DISPLAY BOARD. 10/04/2019 05:34:49 ANNETTE A MENDEZ (AMENDEZ) 1001910510630008537500119242581423 10/16/2019 09:03:46 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
    1516500 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1