BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY SYSTEM

    MDR report key: 20280034 · Received September 23, 2024

    Report

    Report Number
    2919069-2024-00054
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    September 2, 2024
    Report Date
    October 30, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740017170
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    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

    ADDITIONAL INFORMATION ADDED TO B5. THE CELL-DYN RUBY, SERIAL NUMBER: (B)(6) WAS EVALUATED. THE DISTRIBUTOR SERVICE REPRESENTATIVE INDICATED A LOOSE WASTE TUBING FROM THE ANALYZER SPLASHED LIQUID ONTO THE POWER CORD, WHICH CAUSED THE POWER CORD TO BURN. THE CUSTOMER WAS USING A NON-ABBOTT POWER CORD. AS THE INSTRUMENT IS OWNED BY A DEALER, THE DEALER REPLACED THE POWER CORD AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION AFTER THE PART WAS REPLACED. A REVIEW OF THE INSTRUMENT SERVICE HISTORY WAS PERFORMED AND FOUND NO CONTRIBUTING FACTOR ON OR AROUND THE DATE OF THE EVENT. THERE HAVE BEEN NO FURTHER DOCUMENTED OCCURRENCES OF FIRE OR BURNT COMPONENTS AFTER ON-SITE SERVICING WAS PERFORMED. A COMPLAINT SEARCH WAS PERFORMED AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED ASSOCIATED WITH THIS ISSUE OF A LOOSE AND LEAKING/SPLASHING WASTE TUBING, TUBING, TYGON, .125 INCH ID, .250 INCH OD, R-3603, BLK STRIPE, CONTRIBUTING TO A SMOKE/FIRE/BURNING INCIDENT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS INVOLVING REPLACEMENTS OF THE TUBING, TYGON, .125 INCH ID, .250 INCH OD, R-3603, BLK STRIPE. MANUFACTURING DOCUMENTATION WAS REVIEWED AND DID NOT IDENTIFY ANY NON-CONFORMANCE'S ASSOCIATED WITH THE COMPLAINT ISSUE. ADDITIONALLY, LABELING WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE CUSTOMER ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT THE POWER CABLE ON THE CELL DYN RUBY ANALYZER SUDDENLY CAUGHT FIRE. THE POWER CORD AND THE CELERON COMPUTER ASSEMBLY WERE REPLACED. THERE WAS NO VISIBLE DAMAGE TO THE INSTRUMENT, LAB AND TO ANY PERSONNEL. NO REPORT OF INJURIES/EXPOSURE OR IMPACT TO USER SAFETY AND NO IMPACT TO ANALYTICAL PATIENT RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT THE POWER CABLE ON THE CELL DYN RUBY ANALYZER SUDDENLY CAUGHT FIRE. THE POWER CORD AND THE CELERON COMPUTER ASSEMBLY WERE REPLACED. THERE WAS NO VISIBLE DAMAGE TO THE INSTRUMENT, LAB AND TO ANY PERSONNEL. NO REPORT OF INJURIES/EXPOSURE OR IMPACT TO USER SAFETY AND NO IMPACT TO ANALYTICAL PATIENT RESULTS. UPDATE: THE BURNING OF CORD WAS CAUSED BY THE SPLASHING OF LIQUID WASTE FROM LOOSE LIQUID WASTE TUBING. THE LOOSE WASTE TUBING WAS IMMEDIATELY FIXED AND THE BURNT POWER CORD WAS REPLACED USING A NON-ABBOTT POWER CORD. THE CABLE THAT BURNED WAS A NON-ABBOTT CABLE AND WAS REPLACED WITH ANOTHER NON-ABBOTT CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430626 CELL-DYN RUBY SYSTEM COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740017170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown