BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11138826 · Received January 8, 2021

    Report

    Report Number
    2016493-2021-05308
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    May 16, 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 INVOLVED

    Description of Event or Problem · 1

    8100 LVP RECALLS- 05/16/2019 10:43:44 MICHELLE TANGLAO (MTANGLAO) RECALL CONTACT: JERRY FORTMAN/BIOMED/585-683-1086/[email protected] UNIT IS AFFECTED BY R078-LVP AIR IN LINE AND R084-DOOR LATCH RECALL. 05/28/2019 08:00:21 ALAN AGUILAR (ALAAGUIL) INBOUND ERROR 05/31/2019 06:13:24 NGOC T BUI (NBUI) EST - RCL TO MJR 06/11/2019 12:12:06 CRISLEIVY PENA (CRPENA) NPI CONFIRMED UPDATED FROM RCL TO MJR FOR THE MAJOR REPAIR NEEDED PER NGOC T BUI, SERVICE TECH. REPAIR APPROVED BY JERRY FORTMAN, BIOMED AT JERRY [email protected] FOR $365. NEW PO# CE-1116481 06/15/2019 13:14:29 NGOC T BUI (NBUI) LVP DOOR LATCH RECALL COMPLETED. LVP BEZEL POST RECALL COMPLETED. REPLACED BROKEN LOWER HINGE DOOR, AND BROKEN AIL SENSOR RIGHT SIDE. REPLACED BROKEN BOTTOM REAR CASE, AND COVER DOOR. REPLACED CORRODED RIGHT,LEFT IUI, AND FLUID INGRESS FRAME MEMB 06/17/2019 11:11:00 ANNETTE A MENDEZ (AMENDEZ) 1001901752570001464200102839887490 01/31/2020 14:37:33 MIKEE D BALDONADO (MBALDONA) 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
    38776 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1