BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 10745736 · Received October 28, 2020

    Report

    Report Number
    2016493-2020-28030
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Report Date
    August 9, 2016
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS-USED INFORMATION WERE REVIEWED FOR THE SAP AND TRACKWISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DEVICE WAS RETURNED FOR SERVICE. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED 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. CAPA REFERENCE : (B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    08/09/2016 08:26:36 KHATAURI ARMSTEAD (KARMSTEA) CONTACT SHANE MAGEE, BIOMED, [email protected], 718-470-7000X 60024 08/19/2016 06:10:48 GABRIEL LOPES (GLOPES) UNIT RECEIVED WITH: HANDLE BROKEN, TUBE DRIVER BENT, REAR CASE CRACKED BOTTOM LEFT SCREW MOUNT, FRONT CASE CRACKED UNDER PRESSURE SENSOR AND IUIS CONTAMINATED. 01/05/2017 14:05:14 JESSICA GALANG (JGALANG) UPDATED FROM RCL TO MNR FOR THE MINOR REPAIR NEEDED PER GABRIEL LOPES, SERVICE TECH. REPAIR APPROVED BY WILHELM SEDLER, BIOMED DIRECTOR, AT [email protected] FOR $159.30 (55% DISCOUNT APPROVED BY BARBARA WILHITE, BD SERVICE CONTRACTS). NEW PO# IS 1716660696. NPI HAS BEEN CONFIRMED BY HARRY GOLDSMITH, BD SALES REP, AT [email protected] WITH THE CUSTOMER. 01/16/2017 09:12:40 GABRIEL LOPES (GLOPES) STATION 45 TOOLS USED EQ 103106 EQ 102890 EQ 102782 SPLIT NUT RECALL COMPLETED. 01/18/2017 10:58:19 ANNETTE A MENDEZ (AMENDEZ) 1Z9791540271735940 03/27/2018 08:31:59 JOSEPH KUHLS (JKUHLS) 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, PER SWI 1501-006-000. THIS FILE CONTAINED DOCUMENTATION OF PRODUCT DEFICIENCY ALLEGATIONS, PER SWI-151-070-000 AND SWI 1501-096-000, 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, PER SWI 1501-070-000 AND SWI-096-000, WHICH REQUIRED A LEVEL 2 CUSTOMER ADVOCACY QUALITY REVIEW, ALSO PER SWI 1501-070-000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212947 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1