BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 10964053 · Received December 8, 2020

    Report

    Report Number
    2016493-2020-60013
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Report Date
    March 11, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403424267
    PMA / PMN Number
    K133532
    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 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 BARREL CLAMP ASSY ISOLATION RIB DAMAGE DAMAGED/CRACKED HANDLE TUBE DRIVE BENT DAMAGED/CRACKED FLANGE GRIPPER WIPER SEAL DAMAGED DAMAGED/CRACKED REAR & FRONT CASE 03/11/2019 09:53:13 RFC_REPAIRS (RFC_REPAIRS) PO FOR $579. 03/28/2019 21:32:46 DIANE H NGUYEN (DHNGUYEN) REPLACED FRONT CASE, REAR CASE, HANDLE LEFT, FLANGE GRIPPER, TUBE DRIVEARM, SEAL WIPER, IUI RIGHT CONNETOR, AND BARREL CLAMP. PERFORMED PM, AND CALIBRATION. 03/28/2019 21:48:05 DIANE H NGUYEN (DHNGUYEN) RECEIVED THIS DEVICE WITH SOFTWARE V9.33.0.50. 03/29/2019 07:58:58 ANNETTE A MENDEZ (AMENDEZ) 9632001960920413730700480982914357

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432680 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1