BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCOR PEDIATRIC

    MDR report key: 1054429 · Received May 31, 2008

    Report

    Report Number
    1054429
    Event Type
    Death
    Date Received
    May 31, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 31, 2008
    Manufacturer
    BERLIN HEART, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PEDIATRIC PATIENT WHO WAS ADMITTED LAST YEAR WITH CARDIOGENIC SHOCK SECONDARY TO AN IDIOPATHIC DILATED CARDIOMYOPATHY LIKELY DUE TO VIRAL ETIOLOGY. SHE WAS IMMEDIATELY CANNULATED FOR EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. SHE WAS EVENTUALLY WEANED OFF EXTRACORPOREAL MEMBRANE OXYGENATION BUT THEN REQUIRED TO BE PLACED BACK ON EXTRACORPOREAL MEMBRANE OXYGENATION FOR POOR CARDIAC OUTPUT. SHE UNDERWENT IMPLANTATION OF A BERLIN HEART LEFT VENTRICULAR ASSIST DEVICE APPROXIMATELY ONE MONTH AFTER ADMISSION. DESPITE OPTIMAL ANTICOAGULATION, SHE HAS DEVELOPED ENLARGING THROMBUS PRIMARILY ON THE OUTFLOW VALVE OF THE PUMP. A DECISION WAS MADE TO PROCEED WITH PUMP EXCHANGE ON THREE MONTHS AFTER IMPLANTATION. BERLIN HEART LEFT VENTRICULAR ASSIST DEVICE PUMP CHANGE TWO MONTHS LATER, DUE TO BERLIN HEART PUMP DEVELOPED INCREASING THROMBUS FORMATION DESPITE OPTIMAL ANTICOAGULATION. THE PUMP HAD ACCUMULATING THROMBUS PRIMARILY IN THE OUTFLOW VALVE. THE PUMP WAS EXCHANGED AGAIN ONE YEAR POST-IMPLANTATION. TWO MONTHS LATER, HER PUMP DEVELOPED A CRACK IN THE EXTRACORPOREAL PORTION OF THE APICAL CANNULA. THIS WAS CONTROLLED WITH DIGITAL PRESSURE WHILE SHE WAS EMERGENTLY RESUSCITATED. SHE WAS THEN TAKEN EMERGENTLY TO THE OPERATING ROOM FOR A PUMP CHANGE. WHEN A CRACK DEVELOPED IN HER ASSIST DEVICE TUBING, WHICH LED TO BLEEDING AND PROBABLE CNS (AIR) INSULT LEADING TO COLLAPSE AND ALSO HAD DOWN TIME OF ABOUT FIVE MINUTES IN THE OR DURING PUMP CHANGE. SHE HAS BEEN HEMODYNAMICALLY STABILIZED ON THE VENTILATOR BUT HAS BEEN COOLED AND CNS STATUS UNKNOWN. INITIAL EEG DIFFUSE SHOWING NO SEIZURE, BUT CT SUGGEST RIGHT MIDDLE AND POSTERIOR ISCHEMIC EVENT WITH LOSS OF WHITE/GRAY DIFFERENTIATION.SHE HAS BEEN WAITING FOR TRANSPLANT EVER SINCE. AFTER A LONG DISCUSSION WITH THE FAMILY, THEIR WISH WAS TO WITHDRAW FURTHER SUPPORT FOR AND MAKE HER ORGANS AVAILABLE FOR DONATION. ====================== MANUFACTURER RESPONSE FOR IMPLANT -VAD BERLIN HEART, GMBH, BERLIN HEART, GMBH======================HOSPITAL HAS THE DEVICE SEQUESTERED. MANUFACTURER IS AWAITING RETURN OF THE DEVICE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART, INC. P25P-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Death CARDIAC DRUGS| CARDIAC DRUGS