BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 16046301 · Received December 26, 2022

    Report

    Report Number
    2016493-2022-1179055
    Event Type
    Malfunction
    Date Received
    December 26, 2022
    Report Date
    November 7, 2018
    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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: THIS EVENT WAS INADVERTENTLY REPORTED UNDER INCORRECT PRODUCT REGISTRATION NUMBER (MANUFACTURER REPORT NUMBER 9616066-2020-02910). THIS MDR RESUBMISSION NOW REFLECTS THE CORRECT PRODUCT REGISTRATION NUMBER. 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 TRACK WISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE SOURCE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. 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 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.

    Additional Manufacturer Narrative · 0

    ADDITION: UPDATED ADVERSE EVENT CODES (H6).

    Description of Event or Problem · 0

    SYRINGE REPAIR- SHAFT/ CLAWS/ KNOB. ON (B)(6) 2018 09:41:01 (B)(6). SHIPPING & BILLING ADDRESS CONFIRMED. CUSTOMER CANNOT APPROVE LEVEL 2. PLEASE CONTACT CUSTOMER IF ADDITIONAL CHARGES APPLY. NPI.  ON (B)(6) 2018 09:57:03 (B)(6).

    Description of Event or Problem · 0

    SYRINGE REPAIR- SHAFT/ CLAWS/ KNOB 11/07/2018 09:41:01 (B)(6). 11/21/2018 09:57:03 (B)(6). EST - MNR TO MJR 12/04/2018 08:20:04 (B)(6). UPDATED FROM MNR TO MJR FOR THE MAJOR REPAIR NEEDED PER (B)(6), SERVICE TECH. REPAIR APPROVED BY (B)(6). 12/14/2018 09:48:06 (B)(6). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468947 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110 ALARIS SYRINGE MODULE 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown