BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11075492 · Received December 28, 2020

    Report

    Report Number
    2016493-2020-82129
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Report Date
    June 4, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403222054
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REPAIRS OUTSIDE THE RECALL REPAIR WERE ADDRESSED. THE DEVICE WAS REPAIRED, RETESTED, AND RELEASED BACK 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 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- 06/04/2019 13:09:10 RICKY COLEMAN (RCOLEMAN) MARIBEL REGALADO BIOMED 760-940-7711 [email protected] 06/12/2019 12:15:48 NGOC T BUI (NBUI) EST - RCL - MJR 07/09/2019 06:42:29 LAURYNE WASAN (LWASAN) NPI CONFIRMED UPDATED FROM RCL TO MJR FOR THE MAJOR REPAIRS NEEDED PER NGOC BUI, SERVICE TECH. REPAIR APPROVED BY MARIBEL REGALADO, BIOMED, AT BIO [email protected] FOR $365. USE NEW PO# 1083697 07/18/2019 14:32:38 NGOC T BUI (NBUI) LVP BEZEL POST RECALL COMPLETED. REPLACED BROKEN BOTTOM REAR CASE, AND PLATEN ASSY. REPLACED UPPER TRANSDUCER FOR 240.4150 ERROR. REPLACED BROKEN AIL SENSOR CHIP RIGHT SIDE, AND DOOR LATCH SEAR MIDDLE. REPLACED CORRODED RIGHT,LEFT IUI, AND FLUID INGRESS FRAME MEMB. 07/19/2019 10:12:07 ANNETTE A MENDEZ (AMENDEZ) 9632001960920413730700102839915726 11/01/2019 12:11:48 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
    1542269 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403222054

    Patients

    Seq Age Sex Outcome Treatment
    1