BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8120 ALARIS PCA

    MDR report key: 11035096 · Received December 18, 2020

    Report

    Report Number
    2016493-2020-73229
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Report Date
    July 26, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    MEA
    UDI-DI
    10885403812002
    PMA / PMN Number
    K043299
    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. 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

    BROKEN/DAMAGED. CORRODED - IUI. DAMAGED/CRACKED - WIPER SEAL, FLANGE GRIPPER, HANDLE, CASE FRONT, AND BARREL CLAMP ASSY. DAMAGED - LABEL. HINGE DAMAGED - PCA DOOR. BROKEN/DAMAGED- 07/26/2019 13:54:56 RFC_REPAIRS (RFC_REPAIRS) PO FOR $529. LAURYNE TO SUBMIT REPAIR ESTIMATE FOR APPROVAL 08/26/2019 06:44:58 LAURYNE WASAN (LWASAN) UPDATED FROM MNR TO MJR FOR THE MAJOR REPAIRS NEEDED PER ALLAN DULAY, SERVICE TECH. REPAIR APPROVAL CONFIRMED BY RYKIE PRATT, BIOMED, AT [email protected] FOR $579. REPAIR COMPLETION TO REFERENCE PO# 819-1589 - NOT CREDIT CARD. 08/26/2019 06:47:27 LAURYNE WASAN (LWASAN) CORRECTION: APPROVED FOR $529 08/30/2019 12:39:55 ARJIE ANCHETA (ARANCHET) 9632001960920413730700457111900623.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506021 8120 ALARIS PCA PUMP, INFUSION MEA CAREFUSION SD 8120 10885403812002

    Patients

    Seq Age Sex Outcome Treatment
    1