BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 11646452 · Received April 10, 2021

    Report

    Report Number
    2016493-2021-502418
    Event Type
    Malfunction
    Date Received
    April 10, 2021
    Report Date
    February 12, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2909-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS EVALUATED AND REPAIRED THROUGH THE SERVICE REPAIR PROCESS. UPON VISUAL INSPECTION THE SERVICE TECHNICIAN NOTED THAT THEY REPLACED PUNCTURED KEYPAD - REPLACED KEYPAD. ERROR CODE 810.6030 - REFLASHED POLO. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO ELECTRICAL FAILURE OF THE ASSY FR CASE W/ KEYPAD 8015 M2. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 14SEP2018. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS EVALUATED AND REPAIRED THROUGH THE SERVICE REPAIR PROCESS. UPON VISUAL INSPECTION, THE SERVICE TECHNICIAN NOTED, THAT THEY REPLACED PUNCTURED KEYPAD, REPLACED KEYPAD. ERROR CODE 810.6030, REFLASHED POLO. THE FAILURE CODE OTHE WAS USED TO TRACK THE ALARIS SOFTWARE VERSION AS RECEIVED FROM THE CUSTOMER, AND THE SOFTWARE VERSION WHEN DEVICE WAS SENT BACK TO THE CUSTOMER. IT DOES NOT REFLECT A DEVICE FAILURE OR REPRESENT ANY RISK TO THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED, THE DEVICE HAD A MANUFACTURE DATE OF 14SEP2018. THE REVIEW WAS PERFORMED, FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN#: (B)(6) WAS PERFORMED. WHICH CONFIRMED, THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE. WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. BASED ON THE FINDINGS, SERVICE DETERMINED, THAT THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS, DUE TO ELECTRICAL FAILURE OF THE ASSY FR CASE W/KEYPAD 8015 M2. A REVIEW OF THE COMPLAINT HISTORY RECORD IN TRACKWISE AND SAP WAS PERFORMED, FOR THE SN#: (B)(6). WHICH DID NOT CONFIRM, SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER "UNKNOWN/NEEDS REPAIR." THERE WAS NO ADDITIONAL INFORMATION PROVIDED AND NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER, "UNKNOWN/NEEDS REPAIR". THERE WAS NO ADDITIONAL INFORMATION PROVIDED. AND NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED. DEVICE RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER "UNKNOWN/NEEDS REPAIR". THERE WAS NO ADDITIONAL INFORMATION PROVIDED AND NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543952 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1