BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 881630 · Received July 17, 2007

    Report

    Report Number
    2919069-2007-00092
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    June 18, 2007
    Report Date
    June 18, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Removal / Correction Number
    2919069-8/6/07-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TECHNICAL ADVOCATE (CTA) SUGGESTED FLUSHING THE LOWER AND UPPER STAGING HGB PATHWAYS AND INSPECTING THE TUBING IN VALVES 235, 237, 242, 135, 132, 145, AND CHECK THE LUER LOCK FITTING ON THE HGB SYRINGE. THE CUSTOMER STATED THE FITTINGS APPEARED TO BE STRIPPED, AND THE SYRINGE PLUNGER WAS VERY DIFFICULT TO MOVE. THE CUSTOMER REPLACED THE LUER LOCK FITTINGS, PERISTALTIC PUMP TUBING (PPT) #3 AND THE HGB SYRINGE. THE MCHC RESULTS WERE BACK IN ACCEPTABLE LIMITS AND HGB/HCT WERE MATCHING. THE SYSTEM WAS OBSERVED FOR 24 HOURS. THE COMPLAINT ISSUE WAS REOCCURRING. A FIELD SERVICE REPRESENTATIVE (FSR) WAS SENT TO THE ACCOUNT. THE FSR ALIGNED THE SAMPLE PROCESSOR TO IMPROVE PROBE ALIGNMENT WITH CUPS, REMOVED AND CLEANED ALL VALVES ASSOCIATED WITH HGB. PRECISION AND CONTROLS WERE IN RANGE. IN ADDITION THE COMPLAINT ANALYSIS AND TRENDING SYSTEM (CATS) AND TRENDING ANALYSIS SUPPORT SYSTEM (TASS) WERE REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED FOR THE COMPLAINT ISSUE. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4), CONCOMITANT MEDICAL PRODUCTS: CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE, LIST NUMBER 8H49-02. THE CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE, LIST NUMBER 8H49-02, WAS MANUFACTURED ON 30 APRIL 2007 AND WAS IDENTIFIED BY THE VENDOR TO HAVE BEEN MANUFACTURED WITH INSUFFICIENT OR INCONSISTENT AMOUNT OF SILICONE LUBRICANT APPLIED TO THE TIP OF THE SYRINGE PLUNGER. THE AFFECTED SYRINGES WITH A PACKAGE DATE OF 08 MAY 2007 THROUGH 25 JUNE 2007, CAUSED THE CELL-DYN SAPPHIRE ANALYZER TO GENERATE AN ERROR MESSAGE UPON INSTALLATION OF THE SYRINGE OR SHORTLY THEREAFTER. THE CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE WAS DISTRIBUTED FOR THE CELL-DYN SAPPHIRE ANALYZER ONLY AND DID NOT IMPACT OTHER CELL-DYN ANALYZERS. THE ISSUE WAS RESOLVED WHEN A NEW CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE, LIST 8H49-04, WAS MANUFACTURED BY A NEW VENDOR AND RELEASED FOR DISTRIBUTION ON 10 FEBRUARY 2009.

    Description of Event or Problem · 1

    CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) FILTER CLOTTED 13 HOURS AFTER TREATMENT WAS INITIATED. THE FILTER SHOULD BE ABLE TO RUN FOR 96 HOURS. BLOOD WAS ABLE TO BE RETURNED TO PATIENT. FILTER WAS TAKEN DOWN AND REPLACED WITHOUT INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE OF THEIR CELL-DYN SAPPHIRE ANALYZERS WAS GENERATING HIGH MCHC AND HEMOGLOBIN (HGB) RESULTS. ONE PT HAD BEEN RUN ON ANOTHER ANALYZER WITH FOLLOWING RESULTS GENERATED: WBC=14,000/UL, RBC=3.28X10E6/UL, HGB=8.59 G/DL, HCT=28.2%, MCHC=30.4 G/DL. THE SAMPLE WAS REPEATED ON THIS ANALYZER WITH THE FOLLOWING RESULTS: WBC=14,300/UL, RBC=3.27X10E6/UL, HGB=10.9 G/DL, HCT=28.3%, MCHC=38.6 G/DL. THE RESULTS FROM THIS ANALYZER WERE NOT REPORTED AS HGB AND MCHC WERE CONSIDERED SUSPECT. THE SAMPLE HAD BEEN REPEATED DUE TO A FP FLAG. THERE WAS NO IMPACT TO PT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR