BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11092483 · Received December 29, 2020

    Report

    Report Number
    2016493-2020-83444
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Report Date
    August 28, 2019
    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 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

    SYR PCA GRIPPER RECALL 2017-DOM- 08/28/2019 12:59:57 DWAYNE DAVIDS (DDAVIDS) BIOMED CONTACT MARK TAYLOR 859-218-2878 [email protected] ALSO STUCK CLAW 10/08/2019 11:04:57 MELVIN P PASCUA (MPASCUA) RCL ESTIMATED TO MNR REPAIR DUE TO GEAR CLAW (WORN) AND REAR CASE (CRAK BTM SCR) 10/15/2019 08:28:46 LAURYNE WASAN (LWASAN) MAJOR REPAIRS NEEDED PER PERCY MENDOZA, SERVICE TECH, DUE TO CRACKED REAR CASE AND CLAW. 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. 10/17/2019 12:41:10 MELVIN P PASCUA (MPASCUA) RECEIVED W/ INTERNAL S/W 9.33.0.50 10/17/2019 13:27:00 ANNETTE A MENDEZ (AMENDEZ) 1001901712590004021300119242595176 12/15/2019 08:28:49 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
    1556453 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1