BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 4000 110V

    MDR report key: 122894 · Received September 25, 1997

    Report

    Report Number
    2919069-1997-00006
    Event Type
    Malfunction
    Date Received
    September 25, 1997
    Date of Event
    August 25, 1997
    Report Date
    September 24, 1997
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO HAS BEEN SOURCED BY THE MFR. THE EVENT REPRESENTED IS ADDRESSED IN THE DEVICE LABELLING. COMPONENT FAILURE. COMPLAINT EVALUATION: THE CUSTOMER'S COMPLAINT WAS REPRODUCED BY VISUAL INSPECTION OF THE RETURNED PART. THERE WAS A CRACK ALONG THE TOP OF THE REAGENT RESERVOIR. SUBSEQUENT INVESTIGATION REVEALED THAT THE CRACKING WAS CAUSED BY MOLDING STRESS AND THE MATERIAL WAS CHANGED FROM UTEM TO ISOPLAST, AS PER ECO # 18020, EFFECTIVE 10/2/97. ISOPLAST IS A DUPONT MATERIAL MADE ESPECIALLY FOR BIOMEDICAL USE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    ON 08/25/1997, THE PHLEBOTOMY SUPERVISOR WAS SPRAYED IN THE EYES WITH HEMOGLOBIN REAGENT FROM THE HEMOGLOBIN REAGENT RESERVOIR. ACCORDING TO THE ACCOUNT, THE HEMOGLOBIN RESERVOIR HAD DEVELOPED A CRACK AND WAS LEAKING. PRESSURE IN THE THE RESERVOIR HAD CAUSED THE HEMOGLOBIN REAGENT TO SPRAY OUT OF THE CRACK AT THE PHLEBOTOMIST, AS SHE WALKED BY THE INSTRUMENT. THE PHLEBOTOMIST WAS NOT WEARING EYE PROTECTION AT THE TIME AND THE REAGENT SPRAYED IN HER EYES. SHE EXPERIENCED BURNING IN HER EYES AND WENT TO HLTH SVCS FOR THE EYE IRRITATION. TREATMENT PRESCRIBED WAS TO FLUSH THE EYES WITH WATER INITIALLY AND THAN WAS LATER CHANGED TO FLUSHING WITH SALINE. AS OF 08/27/1997, THE PHLEBOTOMIST SAID HER EYE SIGHT WAS NORMAL, BUT A SLIGHT SORENESS REMAINED. HER DR STATED THE SORENESS COULD POSSIBLY BE FROM THE INTENSE FLUSHING AND RECOMMENDED NO FURTHER TREATMENT. MSDS DOCUMENTATION LISTS THE HEMOGLOBIN REAGENT AS CONTAINING SODIUM HYDROXIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 4000 110V AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other