BEUDAMED
    FDA Adverse Event Summary report: N

    DATASCOPE

    MDR report key: 2893245 · Received December 18, 2012

    Report

    Report Number
    2893245
    Date Received
    December 18, 2012
    Date of Event
    December 17, 2011
    Report Date
    December 11, 2012
    Manufacturer
    DTASCOPE CORP, CARDIAC ASSIST DIVISION
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) FEMALE WITH A HISTORY OF BREAST CANCER, DILATED NON ISCHEMIC CARDIOMYOPATHY, MILD CORONARY DISEASE AND ICD PLACEMENT IN 2009, AND RECENTLY DEVELOPED WORSENING CHF WAS ADMITTED TO THE HOSP AND UNDERWENT A TEE WHICH SHOWED SEVERE MITRAL REGURGITATION WITH ANTERIOR FLAIL LEAFLET. SHE WAS ADMITTED TO THE HOSP AND ON (B)(6) 2011 UNDERWENT A COMPLEX MITRAL VALVE REPAIR. PERI-OPERATIVELY, SHE WAS VERY ILL REQUIRING MILRINONE, VASOPRESSIN, EPINEPHRINE, NITRIC OXIDE AND AN INTRA-AORTIC BALLOON PUMA PLACED INTRAOPERATIVELY. SEVERAL HOURS AFTER SURGERY, THERE WAS A RUPTURE OF THE IABP BLOOD IN THE AIR LINE. THE BALLOON PUMP WAS REMOVED. THE PT HAD A CARDIAC INDEX OF 3 AND STABLE HEMODYNAMICS. AFTER THE BALLOON PUMP WAS REMOVED, THE PT'S BP GRADUALLY DECLINED AND THE PT BECAME HYPOTENSIVE. UPON EVAL, HER HEMATOCRIT DROPPED FROM 30 TO 22. THE PT DEVELOPED WORSENING HYPOTENSION THAT WAS UNRESPONSIVE TO VOLUME RESUSCITATION. DUE TO THE RAPID NATURE OF THE PT'S DECLINE, SHE WAS UNABLE TO RETURN TO THE SURGICAL SUITE FAST ENOUGH TO PREVENT HER DEMISE. THE BLEEDING APPEARED TO BE OUT OF PROPORTION TO A SINGLE NEEDLE STICK AND WAS SUSPICIOUS FOR AORTIC DISSECTION FROM THE BALLOON PUMP AS THEY WERE UNABLE TO DRAW BLOOD OR OBTAIN A BLOOD PRESSURE FROM THE TIP OF THE BALLOON. IT WAS ALSO NOTED THAT THE BALLOON DID NOT AUGMENT NORMALLY. WITH THE REMOVAL OF THE INTRA AORTIC BALLOON PUMP, THIS CAUSED MAJOR BLEEDING THAT WAS UNABLE TO BE CONTROLLED. THE PT WAS UNABLE TO BE STABILIZED TO RETURN TO SURGERY. THE PT EXPIRED ON (B)(6) 2011. AT THE TIME OF THE PT DEATH, IT WAS NOT BELIEVED THAT THERE WAS EQUIPMENT FAILURE OR MALFUNCTION CAUSING THE DEATH. UPON FURTHER INVESTIGATION, UNABLE TO CONFIRM IT WAS NOT EQUIPMENT MALFUNCTION OR USER ERROR, THEREFORE, WE ARE REPORTING THIS EVENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE INTRA-AORTIC BALLOON PUMP DSP DTASCOPE CORP, CARDIAC ASSIST DIVISION MEGA 8 FR. 50CC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death