BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11138304 · Received January 8, 2021

    Report

    Report Number
    2016493-2021-03408
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    December 10, 2018
    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

    ADDITIONAL REPAIRS OUTSIDE THE RECALL REPAIR WERE ADDRESSED. THE DEVICE WAS REPAIRED, RETESTED, AND RELEASED BACK 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 NOT RETURNED FOR SERVICING WHICH NOT 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 DOOR LATCH RECALL 2017- 12/10/2018 13:06:38 JEANNETTE KENEFICK (JKENEFIC) CONTACT: NEIL HORTON - (NEW BIOMED CONTACT) 402-609-1106 [email protected] 03/22/2019 08:26:15 NGOC T BUI (NBUI) EST - RCL TO MJR 05/02/2019 08:46:22 LAURYNE WASAN (LWASAN) MAJOR REPAIRS NEEDED PER NGOC BUI, SERVICE TECH, DUE TO BROKEN REAR CASE, BROKEN SUBMECHANISM BEZEL ASSEMBLY AND FAILED PRESSURE SENSORS (BOTH). REPAIR DECLINED BY JOSIAH ABERNATHY, BIOMED, AT 402.609.1106 AS HE REQUESTED THE UNIT BE RETURNED UNREPAIRED FOR ALL ADDITIONAL REPAIRS. PLEASE ONLY COMPLETE THE RECALL. 05/06/2019 12:06:20 NGOC T BUI (NBUI) LVP DOOR LATCH RECALL COMPLETED. LVP BEZEL POST RECALL COMPLETED. RETURN UNREPAIRED - DOOR (THIRD PARTY),BROKEN BOTTOM REAR CASE,FAILED BOTH TRANSDUCERS,CORRODED AIL SENSR, AND CORRODED BOTH IUI. 05/06/2019 13:00:24 ANNETTE A MENDEZ (AMENDEZ) 1001901740920006814400102839853698 01/31/2020 08:33:02 JOSHUA MONK (JMONK) 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
    38667 8100 ALARIS PUMP MODULE PUMP,INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1