BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11000085 · Received December 13, 2020

    Report

    Report Number
    2016493-2020-67982
    Event Type
    Malfunction
    Date Received
    December 13, 2020
    Report Date
    January 14, 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

    Description of Event or Problem · 0

    PROBLEM DESCRIPTION (B)(6)2019 12:06:31 (B)(6) 2019-001471 283724 PROBLEM DESCRIPTION (B)(6)2019 12:28:06 (B)(6) CUSTOMER CALLED EXPERIENCING ERROR CODE 354.6770 ON THEIR 8110. CONDUCTED THE FOLLOWING: - CUSTOMER STATED THEY COULD NOT FIND ERROR CODE IN MANUAL. RECOMMENDED CUSTOMER SEARCH SEPARATING THE FIRST THREE DIGITS, THEN SEARCHING THE LAST FOUR AFTER THE DECIMAL POINT. - BY DOING THIS, THE CUSTOMER AND I DETERMINED THE PRESSURE SENSOR WAS THE CAUSE OF THE ERROR. - INFORMED CUSTOMER IF PRESSURE SENSOR DOES NOT CLEAR FAULT, NEXT WOULD BE THE LOGIC BOARD. - RECOMMENDED CUSTOMER SEND IN FOR REPAIR IF PRESSURE SENSOR DOES NOT CLEAR FAULT. AFTER PROVIDING PART NUMBERS, I EMAIL CUSTOMER OUR FIXED LEVEL REPAIR PRICING LIST. ENDED CALL.

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. 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 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.

    Description of Event or Problem · 1

    (B)(4). CUSTOMER CALLED EXPERIENCING ERROR CODE 354.6770 ON THEIR 8110. CONDUCTED THE FOLLOWING: CUSTOMER STATED THEY COULD NOT FIND ERROR CODE IN MANUAL. RECOMMENDED CUSTOMER SEARCH SEPARATING THE FIRST THREE DIGITS, THEN SEARCHING THE LAST FOUR AFTER THE DECIMAL POINT. BY DOING THIS, THE CUSTOMER AND I DETERMINED THE PRESSURE SENSOR WAS THE CAUSE OF THE ERROR. INFORMED CUSTOMER IF PRESSURE SENSOR DOES NOT CLEAR FAULT, NEXT WOULD BE THE LOGIC BOARD. RECOMMENDED CUSTOMER SEND IN FOR REPAIR IF PRESSURE SENSOR DOES NOT CLEAR FAULT. AFTER PROVIDING PART NUMBERS, I EMAIL CUSTOMER OUR FIXED LEVEL REPAIR PRICING LIST. ENDED CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463331 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1