BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11085361 · Received December 28, 2020

    Report

    Report Number
    2016493-2020-83024
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Report Date
    June 8, 2018
    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

    THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS REPAIRED, RETESTED AND RETURNED 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 RECALL CARRIAGE ASSY- TUBE DRIVE BENT, BARREL CLAMP ASSY- DAMAGED/CRACKED, CARRIAGE ASSY- MISALIGNMENT, CASE FRONT- DAMAGED/CRACKED, CASE REAR- DAMAGED/CRACKED, FLANGE GRIPPER- DAMAGED/CRACKED, CARRIAGE ASSY- SPLIT NUT DAMAGED/WORN THERE WAS NO PATIENT INVOLVEMENT SYRINGE SPLIT NUT TWO RECALL- 06/08/2018 17:41:07 WILLIAM BURDETTE (WBURDETT) FOR ADDITIONAL REPAIRS PLEASE CONTACT RYAN WALKER, BIOMED, [email protected], 208-381-2222 06/27/2018 18:38:39 DIANE H NGUYEN (DHNGUYEN) MISSED - EST - RCL TO MJR. 07/05/2018 07:57:02 JESSICA GALANG (JGALANG) UPDATED FROM RCL TO MJR FOR THE MAJOR REPAIR NEEDED PER DIANE NGUYEN, SERVICE TECH. REPAIR APPROVED BY DAN SCHILLING AT [email protected] FOR $579. NEW PO# IS 1101643061-0-REP. NPI 07/06/2018 19:56:00 DIANE H NGUYEN (DHNGUYEN) RECEIVED THIS DEVICE WITH SOFTWARE V9.33.0.50. SYRINGE SPLIT NUT 2 RECALL COMPLETED. REPLACED FRONT CASE, REAR CASE, FLANGE GRIPPER RETAINER, BARREL CLAMP, SPLIT NUTS, TUBE DRIVEARM, AND IUI CONNECTORS. PERFORMED PM, AND CALIBRATION. 07/10/2018 08:59:10 ANNETTE A MENDEZ (AMENDEZ) 1Z9791540272129924 10/24/2019 11:14:59 JOSHUA MONK (JMONK) 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
    1546226 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1