BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11085216 · Received December 28, 2020

    Report

    Report Number
    2016493-2020-83050
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Report Date
    September 13, 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

    THE CUSTOMER REPORTED PROBLEM WAS UNCONFIRMED. THE DEVICE WAS RETURNED UNREPAIRED TO THE CUSTOMER. BASED ON THE FILE REVIEW, INFUSION PRODUCTS GLOBAL CUSTOMER SUPPORT OPERATIONS. 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.

    Description of Event or Problem · 1

    SYR PCA GRIPPER RECALL 2017-DOM- 09/13/2019 09:02:04 DWAYNE DAVIDS (DDAVIDS) BIOMED CONTACT MARK TAYLOR 859-218-2878 [email protected] 10/09/2019 12:07:31 ALLAN DULAY (ADULAY) UNIT RECEIVED WITH SOFTWARE V9.33.0.50 SYRINGE GRIPPER RECALL IS NOT CALLED OUT IN ZSM0054 AND IS NOT WITHIN AFFECTED POPULATION. EST - RCL TO MJR 10/15/2019 08:20:15 LAURYNE WASAN (LWASAN) MAJOR REPAIRS NEEDED PER ALLAN DULAY, SERVICE TECH, DUE TO CRACKED FRONT CASE, KEYPAD, AND CRACKED BARREL CLAMP. REPAIR DECLINED BY MARK TAYLOR, BIOMED, AT [email protected] AS HE REQUESTED THE UNIT BE RETURNED UNREPAIRED FOR ALL ADDITIONAL REPAIRS. PLEASE ONLY COMPLETE THE RECALL. 10/21/2019 10:58:28 ANNETTE A MENDEZ (AMENDEZ) 1001901713170004021300119242597889 11/05/2019 09:13:05 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
    1547428 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1