BEUDAMED
    FDA Adverse Event Death Summary report: N

    SSCOR, INC.

    MDR report key: 2510597 · Received March 26, 2012

    Report

    Report Number
    2022724-2012-00001
    Event Type
    Death
    Date Received
    March 26, 2012
    Date of Event
    December 19, 2011
    Report Date
    March 21, 2012
    Manufacturer
    SSCOR, INC.
    Product Code
    BTA
    PMA / PMN Number
    K041154
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN SSCOR RECEIVED THE DEVICE, WE FIRST TESTED THE DEVICE TO DETERMINE IF THE DEVICE OPERATED TO SPECS. ALL OF THE PERFORMANCE OUTPUTS MET OR EXCEEDED SPECS, THE DEVICE WAS PERFORMING TO SPEC. THE DEVICE WAS THEN TESTED TO EXPLORE THE HEALTH CARE PROFESSIONAL'S CLAIM THAT IT WOULD NOT SUCTION A FROTHY LIQUID. THE DEVICE WAS SETUP PER THE CLAIMS OF THE HEALTH CARE PROFESSIONAL, A CANISTER WAS ATTACHED TO THE DEVICE, A 6' LENGTH OF PT TUBING WAS ATTACHED TO THE CANISTER, AND A SIZE 14 FRENCH CATHETER WAS ATTACHED TO THE PT TUBING. A FOAMY MIXTURE WAS CREATED FROM DISH SOAP AND THE QUICKDRAW WAS USED TO SUCTION THE FOAM FROM THE VESSEL. THE FOAM WAS INITIALLY SUCTIONED AT A NEGATIVE PRESSURE SETTING OF 100MMHG. SSCOR THEN USED ANOTHER WIDELY USED SUCTION DEVICE AS A CONTROL AND REPEATED THE TEST. THE MODEL WAS USED TO SUCTION THE FOAM SOLUTION CREATED FROM DISH SOAP WITH THE REGULATOR GAUGE SET AT 100MMHG. THERE WAS NOT A NOTICEABLE DIFFERENCE IN THE RATE OF FOAM REMOVAL OF THE TWO DEVICE WHEN SUCTIONING THE FOAM SOLUTION AT A NEGATIVE PRESSURE SETTING OF 100MMHG. BOTH DEVICES WERE THEN SET TO THE MAXIMUM VACUUM SETTING AND ONCE AGAIN THE FOAM WAS SUCTIONED USING BOTH DEVICES. THERE WAS NOT A NOTICEABLE DIFFERENCE IN THE RATE OF FOAM REMOVAL BETWEEN THE TWO DEVICES AT THE MAXIMUM VACUUM LEVELS. A FOAMY MIXTURE WAS THEN CREATED FROM A LIQUID EGG SOLUTION AND THE TWO TESTS DESCRIBED ABOVE WERE DUPLICATED. THE RESULTS WERE THE SAME AS THE DISH SOAP TEST. THERE WAS NOT A NOTICEABLE DIFFERENCE IN THE RATE OF FOAM REMOVAL BETWEEN THE TWO DEVICES AT NEGATIVE PRESSURE SETTINGS OF 100MMHG AND MAXIMUM VACUUM LEVELS.

    Description of Event or Problem · 1

    ON 3/15/2012, SSCOR BECAME AWARE OF AN ADVERSE EVENT THAT TOOK PLACE (B)(6) 2011. (B)(6) RESPONDED TO A CALL FOR A CARDIAC ARREST. WHEN THEY ARRIVED AT THE CALL, THEY FOUND THAT THE PT HAD PULLED OUT HIS "TRACHEAL TUBE" WHICH CAUSED "ACUTE MULTI-SYSTEM FAILURE." THE FIRST RESPONDER, (B)(6), WENT TO CLEAR THE AIRWAY (TRACHEOSTOMY) OF A "FROTHY SUBSTANCE AND A LITTLE BLOOD." SHE USED THE SSCOR MODEL 2400 "QUICKDRAW" WITH A SHORT LENGTH OF TUBING AND A "FRENCH TIP" CATHETER. SHE FOUND SHE WAS UNABLE TO SUCTION THE SUBSTANCE FROM THE TRACHEOSTOMY. A SECONDARY SUCTION UNIT WAS USED AND THE PT WAS TRANSPORTED TO THE ER WHERE HE WAS PRONOUNCED DEAD ON ARRIVAL. THE ORIGINAL REPORTER OF THE ADVERSE EVENT STATED "WITH AN ALREADY COMPRISED VASCULAR AND RESPIRATORY SYSTEM, HE DIED AS A RESULT OF 'NATURAL' CAUSES. THE CAUSE OF DEATH IS 'ACUTE MULTI-SYSTEM FAILURE'."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SSCOR, INC. 2400 QUICKDRAW BTA SSCOR, INC. 2400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| R