BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11052628 · Received December 21, 2020

    Report

    Report Number
    2016493-2020-71454
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Report Date
    February 28, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-1768-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS-USED INFORMATION WERE REVIEWED FOR THE SAP AND TRACK WISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE SOURCE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. 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 BEZEL POST RECALL 2017- 02/28/2018 14:38:29 SANDRA J MCDONALD (SMCDONAL) LVP BEZEL POST RECALL 2017 JAMES HARLING 864-560-7867 EMAIL: [email protected] 03/12/2018 09:57:00 JESSICA GALANG (JGALANG) UPDATED FROM RCL TO MJR FOR THE MAJOR REPAIR NEEDED PER TUAN NGUYEN, SERVICE TECH. REPAIR APPROVED BY RAY HARLING AT [email protected] FOR $365. NEW PO# IS 1122528-BILL. NPI 03/13/2018 11:03:21 ARJIE ANCHETA (ARANCHET) 1Z9791540272918652 07/05/2019 11:51:32 JOSEPH KUHLS (JKUHLS) FILE REOPENED TO ADD TRACK WISE PR NUMBER TO THE DEVICE DATA FIELD. THE ORIGINAL REPORTED PROBLEM CODE WAS FOUND TO BE INCORRECT AFTER REVIEW OF THIS FILE. IT WAS DETERMINED THE ORIGINAL CODE SHOULD HAVE BEEN BROK BASED ON THE CUSTOMERS REPORTED PROBLEM 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, PER SWI 1501-006-000. THIS FILE CONTAINED DOCUMENTATION OF PRODUCT DEFICIENCY ALLEGATIONS, PER SWI-151-070-000 AND SWI 1501-096-000, 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, PER SWI 1501-070-000 AND SWI-096-000, WHICH REQUIRED A LEVEL 2 CUSTOMER ADVOCACY QUALITY REVIEW, ALSO PER SWI 1501-070-000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509593 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1