BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL80 FLEX CO-OX ANALYZER

    MDR report key: 1340168 · Received March 5, 2009

    Report

    Report Number
    2027541-2009-00002
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    January 1, 2009
    Report Date
    February 6, 2009
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    PMA / PMN Number
    K080370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED FAILURE COULD NOT BE DUPLICATED. THE DEVICE IS DESIGNED TO PREVENT ISSUES SIMILAR TO THE ALLEGED FAILURE. NUMEROUS ATTEMPTS HAVE BEEN MADE REQUESTING THAT THE HOSPITAL DESCRIBE THE INCIDENT IN GREATER DETAIL. NONE OF THE RESPONSES FROM THE HOSPITAL HAVE PROVIDED SUFFICIENT INFO TO REPLICATE THE EXACT CIRCUMSTANCES THAT LEAD TO THE ALLEGED FAILURE. ONE RESPONSE INDICATED THAT AT THE TIME OF THE EVENT THE ANALYZER WAS NOT BEING USED AND WAS LOCATED IN A CONFERENCE ROOM. QUALITY CONTROL SOLUTION ALLEGEDLY SPRAYED THE HOSPITAL EMPLOYEE. THE FLUID PATH TAKEN BY A QUALITY CONTROL SOLUTION IS NEARLY IDENTICAL TO THE FLUID PATH TAKEN BY A BLOOD SAMPLE. IF THE SAME ALLEGED MALFUNCTION OCCURRED WITH BLOOD INSTEAD OF NON-HAZARDOUS QUALITY CONTROL SOLUTION, BLOOD COULD HAVE SPRAYED THE HOSPITAL EMPLOYEE. EVALUATION SUMMARY: THE ABL80 FLEX CO-OX ANALYZER (B) (4) WAS ANALYZED BY THE DISTRIBUTOR, (B) (4). IN AN ATTEMPT TO DUPLICATE THE SPRAYING INCIDENT: THE WASTE MANIFOLD WAS COMPLETELY BLOCKED, RESULTING IN THE WASTE PUMP TUBING DISCONNECTING AND LEAKING UNDERNEATH THE SOLUTION PACK. THE WASTE PUMP TUBING WAS TIED OFF WITH A ZIP TIE. THIS FORCED THE SOLUTION TO BACK UP AND LEAK OUT OF THE SENSOR CASSETTE WASTE PORT. IN BOTH OF THE ABOVE CASES, THE OUTCOME WAS A LEAK OF SOLUTION FROM THE ANALYZER. SOLUTION DID NOT SPRAY FROM THE ANALYZER. THE ANALYZER FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    ON 02/06/2009, A DISTRIBUTOR REPORTED THAT A COMPLAINT WAS RECEIVED INDICATING THE UNIT HAD A LEAK THAT SPRAYED A HOSPITAL EMPLOYEE DURING A VIDEO CONFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL80 FLEX CO-OX ANALYZER PH, BLOODGAS, ELECTROLYTE ANALYSIS SYSTEM CHL SENDX MEDICAL, INC. 393-841

    Patients

    Seq Age Sex Outcome Treatment
    1