BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11292141 · Received February 8, 2021

    Report

    Report Number
    2016493-2021-24173
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Report Date
    August 24, 2017
    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

    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

    SYRINGE SPLIT NUT TWO KNOB ACTUATOR- DAMAGED/CRACKED, CARRIAGE ASSY- BINDING/JAMMED, BARREL CLAMP ASSY- DAMAGED/CRACKED, MISALIGNED 08/24/2017 15:46:11 WILLIAM BURDETTE (WBURDETT) FOR ADDITIONAL REPAIRS PLEASE CONTACT RODGER ABBOTT, BIOMED [email protected], 513-636-2587 03/26/2018 09:31:42 DWAYNE DAVIDS (DDAVIDS) RECALL CONTACT: CALEB KINDERMAN CLINICAL ENGINEERING TECH 513-518-2166 [email protected] 04/03/2018 08:01:35 FRANCISCO R ZAMORA (FZAMORA) MINOR REPAIR. 04/17/2018 10:19:48 LAURYNE WASAN (LWASAN) THERE WAS NO PATIENT INVOLVEMENT. UPDATED FROM RCL TO MNR FOR THE MINOR REPAIRS NEEDED PER FRANK ZAMORA, SERVICE TECH. REPAIR APPROVED BY ROBERT MARTIN, BIOMED, AT [email protected] FOR $354. USE NEW PO# 1100088888 04/19/2018 09:37:12 ANNETTE A MENDEZ (AMENDEZ) 1Z9791540270518294 01/17/2019 06:16:59 JOSEPH KUHLS (JKUHLS) FILE REOPENED TO ADD TRACK WISE PR NUMBER TO THE DEVICE DATA FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190553 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1