BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11138487 · Received January 8, 2021

    Report

    Report Number
    2016493-2021-03374
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    January 30, 2020
    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

    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. ADDITIONAL REPAIRS OUTSIDE THE RECALL REPAIR WERE ADDRESSED. INFUSION PRODUCTS GLOBAL CUSTOMER SUPPORT OPERATIONS. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    SYR PCA GRIPPER RECALL 2017-DOM FLANGE GRIPPER- DAMAGED/CRACKED CASE FRONT- DAMAGED/CRACKED HANDLE- DAMAGED/CRACKED CASE REAR- DAMAGED/CRACKED CARRIAGE ASSY- BINDING/JAMMED RECALL AFFECTED 04/11/2019 13:15:42 DWAYNE DAVIDS (DDAVIDS) BIOMED CONTACT ERIC PICKETT 832-797-9720 [email protected] 06/04/2019 13:23:08 LAURYNE WASAN (LWASAN) THERE WAS NO PATIENT INVOLVEMENT CONFIRMED UPDATED FROM RCL TO MNR FOR THE MINOR REPAIRS NEEDED PER PERCY MENDOZA, SERVICE TECH. REPAIR APPROVED BY CATHY PITT, PURCHASING, AT [email protected] FOR $354. USE NEW PO#19-1088050 06/07/2019 10:58:50 ANNETTE A MENDEZ (AMENDEZ) 1001901751090007703000102839879231 01/30/2020 13:49:37 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
    39408 8110 ALARIS SYRINGE PUMP PUMP,INFUSION FRN CAREFUSION SD 8110 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1