BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINEAR 7.5 FR. 34CC IAB

    MDR report key: 2153262 · Received July 1, 2011

    Report

    Report Number
    2248146-2011-00296
    Event Type
    Death
    Date Received
    July 1, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 12, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT FAXED FROM FACILITY STATED THE FOLLOWING: THE PUMP STOPPED PUMPING. CANNOT REMEMBER WHAT ALARM WENT OFF. JUST REMEMBER SEEING BLOOD INSIDE CATHETER. HOURS AFTER BALLOON WAS REMOVED, RETROPERITONEAL BLEED, HOWEVER NO HEMATOMA SEEN WHEN CATHETER REMOVED. DURING FOLLOW UP PHONE CONVERSATION WITH (B)(6) ON (B)(6) 2011, (B)(6) WAS INFORMED THAT THE PATIENT HAD DIED. NO INFORMATION WAS OR COULD BE PROVIDED AS TO THE DATE OR CAUSE OF DEATH. FOLLOWUPS WERE MADE REGARDING THE CAUSE OF DEATH ON (B)(6) 2011 BUT NO INFORMATION WAS RECEIVED. RECEIVED PHONE CALL FROM FACILITY ON (B)(6) 2011 REQUESTING AN ADDITIONAL PACKAGE TO RETURN THE DEFECTIVE DEVICE. FACILITY REPRESENTATIVE WAS ASKED ABOUT THE PATIENT DEATH AND ONCE AGAIN NO INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR 7.5 FR. 34CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 0684-00-0474 2565

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death