BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 180820 · Received August 1, 1998

    Report

    Report Number
    2248146-1998-00854
    Event Type
    Malfunction
    Date Received
    August 1, 1998
    Date of Event
    March 4, 1998
    Manufacturer
    *
    Product Code
    DSP
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-00902) ON 7/6/98, DATASCOPE RECEIVED THE MEDWATCH FORM FROM THE USER/FACILITY; UF/DIST REPORT NUMBER 070022-1998-0003 AND THE FOLLOWING INFORMATION WAS REPORTED: A SMALL AMOUNT OF BLOOD WAS NOTED IN THE BALLOON TUBING. THE "BLOOD LOSS" ALARM SOUNDED FROM THE PUMP. BALLOON REMOVAL WAS DIFFICULT TO TO ACHIEVE. THE PATIENT WAS NOTED BY THE ATTENDING CT SURGEON NOT TO HAVE SIGNIFICANT CALCIUM ON THE AORTA. THE PATIENT WAS THEN CLOSELY OBSERVED FOR SIGNS OF FEMORAL ARTERY INJURY. ON 9/17/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE IABP BEGAN TO ALARM. THE TUBING WAS NOTED TO HAVE BLOOD IN IT. THE ALARM MEMO INDICATED TO CHECK THE CATHETER. IT WAS NOT POSSIBLE TO FILL THE IAB. THE DOCTOR WAS CALLED IN IMMEDIATLELY TO REMOVE THE CATHETER. THE IAB WAS REMOVED WITH SOME DIFFICULTY. AFTER REMOVAL OF THE IAB, THE PATIENT DID WELL. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT ON 3/4/98. IAB REMOVAL WAS SCHEDULED LATER THAT DAY ON 3/4/98. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 7/6/98 AND 9/17/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 7/6/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * DSP * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR