BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8120 ALARIS PCA

    MDR report key: 11092668 · Received December 29, 2020

    Report

    Report Number
    2016493-2020-84403
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Report Date
    May 22, 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

    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 RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    BROKEN/DAMAGED DAMAGED/CRACKED - FLANGE GRIPPER, BARREL CLAMP ASSY, HANDLE, CASE REAR, CASE FRONT. FLANGE GRIPPER- WIPER SEAL DAMAGED LABEL- DAMAGED SOFT FAULT- OTHER- SPECIFY IN COMMENTS 05/22/2019 11:08:53 RFC_REPAIRS (RFC_REPAIRS) PO FOR $529. PLEASE EMAIL ESTIMATE AND WHO TO CALL WITH CREDIT CARD AUTHORIZATION. 06/17/2019 09:21:26 LAURYNE WASAN (LWASAN) PER RYKIE PRATT, BIOMED, AT [email protected], MAJOR REPAIRS ARE APPROVED FOR $529 AS NOTED. NO CREDIT CARD IS NEEDED FOR REPAIR APPROVAL. PLEASE REFERENCE PO# FOR REPAIRS 819-1040 06/18/2019 12:28:56 ANNETTE A MENDEZ (AMENDEZ) 9632001960920413730700102839888946.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556514 8120 ALARIS PCA PUMP, INFUSION MEA CAREFUSION SD 8120 10885403812002

    Patients

    Seq Age Sex Outcome Treatment
    1