BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY SYSTEM

    MDR report key: 20369764 · Received October 4, 2024

    Report

    Report Number
    2919069-2024-00057
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 12, 2024
    Report Date
    October 28, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE CELL-DYN RUBY, SERIAL NUMBER (B)(6) WAS EVALUATED. THE ABBOTT POWER CORD (CORD, PWR, 125VAC/10A), WHICH PLUGGED INTO THE CUSTOMER¿S UNINTERRUPTIBLE POWER SUPPLY (UPS), WAS BURNED. IT WAS SUSPECTED THAT THE ABBOTT POWER CORD (CORD, PWR, 125VAC/10A) MAY NOT HAVE BEEN PLUGGED INTO THE UPS PROPERLY, WHICH LED TO THE OVERHEATING OF THE ABBOTT POWER CORD (CORD, PWR, 125VAC/10A). THE ANALYZER RETURNED TO NORMAL OPERATION AFTER REPLACEMENT OF THE ABBOTT POWER CORD (CORD, PWR, 125VAC/10A). THE ABBOTT POWER CORD (CORD, PWR, 125VAC/10A) IS SPECIFICALLY USED WITH THE CELL-DYN RUBY ANALYZER. THERE HAVE BEEN NO FURTHER DOCUMENTED OCCURRENCES OF BURNT COMPONENTS AFTER THE ABBOTT POWER CORD (CORD, PWR, 125VAC/10A) WAS REPLACED. THE INSTRUMENT SERVICE HISTORY WAS PERFORMED AND FOUND NO CONTRIBUTING FACTOR ON OR AROUND THE DATE OF THE EVENT. A COMPLAINT SEARCH FOR THE PAST 12 MONTHS ONLY IDENTIFIED THIS SINGLE EVENT ASSOCIATED WITH A BURNT ABBOTT POWER CORD (CORD, PWR, 125VAC/10A). THE COMPLAINT SEARCH DID IDENTIFY ONE ADDITIONAL COMPLAINT, HOWEVER IT WAS DETERMINED TO BE NOT RELATED TO THE CURRENT COMPLAINT ISSUE AS THE CUSTOMER UTILIZED A NON-ABBOTT POWER CABLE ON THE RUBY ANALYZER. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES FOR THE ABBOTT POWER CORD (CORD, PWR, 125VAC/10A). LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT THE POWER CABLE FROM THE CELL-DYN RUBY ANALYZER THAT PLUGS INTO A UPS WAS FOUND BURNED. THE POWER CABLE WAS REPLACED. THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT THE POWER CABLE FROM THE CELL-DYN RUBY ANALYZER THAT PLUGS INTO A UPS WAS FOUND BURNED. THE POWER CABLE WAS REPLACED. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726201 CELL-DYN RUBY SYSTEM COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown