BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11191303 · Received January 19, 2021

    Report

    Report Number
    2016493-2021-12314
    Event Type
    Malfunction
    Date Received
    January 19, 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

    ADDITIONAL REPAIRS OUTSIDE THE RECALL REPAIR WERE ADDRESSED. THE DEVICE WAS REPAIRED, RETESTED, AND RELEASED BACK TO THE CUSTOMER. 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

    SYRINGE SPLIT NUT TWO - ISSUE LEFT/RIGHT HANDLE, FRONT COVER, REAR CASE, BARREL CLAMP, FLANGE GRIPPER, SEAL WIPER, TOP DISK HOLDER, SLEEVE DRIVER, AND LINEAR SENSOR. PERFORMED CALIBRATION AND PM. SYRINGE SPLIT NUT TWO- 08/24/2017 15:46:04 WILLIAM BURDETTE (WBURDETT) FOR ADDITIONAL REPAIRS PLEASE CONTACT RODGER ABBOTT, BIOMED [email protected], 513-636-2587 04/23/2018 10:16:29 SUZANNE XAYRATH (SXAYRATH) NEW RECALL CONTACT: CALEB KINDERMAN-BIOMED TECH 513-518-2166 [email protected] 05/22/2019 13:07:56 JOVELYN MARTIN (JOBMARTI) ***CONTACT JAMES BUGGE CE #513-636-6650 <[email protected]> UNIT IS ALSO AFFECTED BY SYR PCA GRIPPER RECALL 2017 - R090. 06/05/2019 09:51:55 ALLAN DULAY (ADULAY) UNIT RECEIVED WITH SOFTWARE V9.33.0.50 EST - RCL TO MJR 08/12/2019 11:10:13 LAURYNE WASAN (LWASAN) NPI CONFIRMED UPDATED FROM RCL TO MJR FOR THE MAJOR REPAIRS NEEDED PER ALLAN DULAY, SERVICE TECH. REPAIR APPROVED BY ABBY SHAY, BIOMED, AT ABBY.SH [email protected] FOR $579. USE NEW PO# 1100106105 08/16/2019 10:46:53 LAURYNE WASAN (LWASAN) TECH CONVERSATION CONFIRMED. NO ERROR CODES IN ERROR LOG 08/19/2019 07:10:41 ANNETTE A MENDEZ (AMENDEZ) 1001910572860004522900119242540880 05/12/2020 19:21:33 MIKEE D BALDONADO (MBALDONA) DURING THE REPAIR PROCESS, IT WAS DETERMINED THAT THE ORIGINAL PROBLEM CODE SHOULD HAVE BEEN BROK (BROKEN/DAMAGED) FOR COMPLAINT TRENDING PURPOSES. FILE REOPENED TO ADD TRACK WISE PR NUMBER TO THE DEVICE DATA FIELD. 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 OR A NO PATIENT INVOLVED STATEMENT. THIS FILE CONTAINED DOCUMENTATION OF PRODUCT DEFICIENCY ALLEGATIONS, 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, WHICH REQUIRED A LEVEL 2 CUSTOMER ADVOCACY QUALITY REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94073 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1