BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 9512452 · Received December 23, 2019

    Report

    Report Number
    2919069-2019-00118
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    December 3, 2019
    Report Date
    February 26, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740016616
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE REQUESTED SITE VISIT, THE FIELD SERVICE REPRESENTATIVE (FSR) NOTICED A BURNING SMELL AND THE INSTRUMENT WAS POWERED OFF. AFTER INSPECTING THE ANALYZER, LEAKING AND A CIRCUIT BOARD WITH BURNED CIRCUITS WERE FOUND, BUT NO FIRE OR VISIBLE SMOKE WAS OBSERVED. THE FSR REPLACED THE 8921279803 ASSY, PRE-HTR CDSPHR, ROHS, AND 8932075802 SAMPLE CUP, REAR, WHICH RESOLVED THE ISSUE. INSTRUMENT OPERATION WAS CONFIRMED TO BE WITHIN SPECIFICATION AFTER THE REPLACEMENTS WERE MADE. AN ANALYSIS OF THE FAILED PART DETERMINED THAT THE SHORT CIRCUIT WAS CAUSED BY BUILD-UP OF LIQUID AND SALTS COMING FROM THE LEAK DRIPPING FROM THE RBC CUP (8932075802 SAMPLE CUP, REAR) ONTO THE ELECTRONICS (8921279803, ASSY, PRE-HTR CDSPHR, ROHS), CAUSING THE ELECTRONICS TO SHORT CIRCUIT, RESULTING IN THE PRE-HEATER AND ATTACHED CABLE COMPONENTS TO FAIL. RETURNS WERE NOT NECESSARY FOR THE INVESTIGATION. A 12-MONTH REVIEW FOR THE ASSY, PRE-HTR CDSPHR, ROHS (PART NUMBER 88921279803) AND THE SAMPLE CUP, REAR (PART NUMBER 8932075802) DID NOT IDENTIFY ANY TRENDS FOR THE PARTS REGARDING THE CURRENT COMPLAINT ISSUE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ASSY, PRE-HTR CDSPHR, ROHS (PART NUMBER 88921279803) OR THE SAMPLE CUP, REAR (PART NUMBER 8932075802).

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERROR RELATED TO THE WBC DILUTION CUP TEMPERATURE ON THE CELL DYN SAPPHIRE ANALYZER. WHEN THE ABBOTT TSS ARRIVED ON SITE, HE SMELLED A BURNING SMELL. THERE WAS NO VISIBLE FIRE OR SMOKE OBSERVED. DURING THE SITE VISIT THE TSS FOUND A CHARRED COMPONENT DUE TO LEAKING. THERE WAS NO IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304176 CELL-DYN SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 08H00-01 00380740016616

    Patients

    Seq Age Sex Outcome Treatment
    1