BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABL77 ANALYZER

    MDR report key: 776100 · Received August 22, 2006

    Report

    Report Number
    2027541-2006-00001
    Event Type
    Other
    Date Received
    August 22, 2006
    Date of Event
    July 19, 2006
    Report Date
    August 22, 2006
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT EVENT DATE: 2006. INCIDENT REPORT DATE: 07/27/06. FOLLOW UP EMAIL: 08/10/06. THE REPORTED DEVICE SERVICED AND PLACED BACK IN TO USE AT THE HOSPITAL. MDR 2027541-2006-00001 INITIATED: 08/22/06. PHOTOS OF RETURNED COMPONENTS FOR WASTE PUMP, VALVE BOARD AND GASKET SHOWED NO BLOOD, BUT WERE CORRODED.

    Description of Event or Problem · 1

    ON JULY 27TH, SENDX WAS NOTIFIED BY EMAIL OF A POTENTIAL INCIDENT. THE USER WAS SPLASHED WITH BLOOD DURING A MEASUREMENT IN 2006. THEY SAY "THAT, IT SEEMED THAT, THE BLOOD WENT OUT OF THE REAR SIDE AT THE SENSOR CASSETTE. AND THE BLOOD REACHED THE EYES OF THE USER. ANOTHER EMAIL WAS SENT 08/10/06 DESCRIBING THE SUSPECT ANALYZER WAS BLOCKED IN THE WASTE DRAIN FOR 2 DAYS PRIOR TO THE INCIDENT. THERE WAS NO ATTEMPT BY THE USER TO REMOVE THE BLOCKAGE, CALL SERVICE OR TAKE ANY ACTION TO CLEAR THE BLOCKAGE. MAINTAINING THE WASTE DRAIN IS DOCUMENTED IN THE OPERATOR'S MANUAL. USING THIS ANALYZER WITH A KNOWN WASTE DRAIN BLOCKAGE MAY HAVE CONTRIBUTED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL77 ANALYZER PH, BLOOD GAS AND ELECTROLYTE SYSTEM CHL SENDX MEDICAL, INC. 391-858 57104

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization