BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 34 CC. IAB

    MDR report key: 179039 · Received July 23, 1998

    Report

    Report Number
    2248146-1998-00841
    Event Type
    Malfunction
    Date Received
    July 23, 1998
    Date of Event
    July 16, 1998
    Report Date
    July 17, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLOOD BACKED INTO THE SAFETY CHAMBER AND THE IAB WAS REMOVED. A SECOND IAB WAS INSERTED. ON 8/5/98, DATASCOPE REC'D THE MEDWATCH FORM FROM THE USER FACILITY; UF/DIST REPORT NUMBER: 14-0258-1998-0148 AND THE FOLLOWING WAS REPORTED: THE ALARMS SOUNDED FROM THE PUMP. THE PT WAS ALERT AND ORIENTED WHEN CHECKED. THE PT DENIED THE PRESENCE OF CHEST PAINS. AT THIS TIME, THE IAB CATHETER WAS CHECKED AND BLOOD WAS FOUND IN THE TUBING. IABP WAS STOPPED. THE DR WAS MADE AWARE OF THE SITUATION AND HE ORDERED THAT THE IAB BE REMOVED. THE HOUSE DR REMOVED THE IAB FROM THE PT WITHOUT COMPLICATION. ANOTHER IAB WAS INSERTED INTO THE PT. THERE WAS NO PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. THE PT WAS STABLE AFTER THE EVENT. [EVENT COMPLICATIONS]: NONE FROM THE EVENT-REPORTED 7/17/98 AND 8/5/98. [PT'S CURRENT STATUS]; STABLE-RPT'D 8/5/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 34 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0206-01 11/17/99

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR