BEUDAMED
    FDA Adverse Event Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 188284 · Received September 16, 1998

    Report

    Report Number
    2248146-1998-01010
    Date Received
    September 16, 1998
    Date of Event
    August 31, 1998
    Report Date
    August 31, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01073) THE IAB LEAKED. BLOOD WAS NOTED IN THE TUBING AND BACK INTO THE PUMP. ON 9/10/98, DATASCOPE RECEIVED THE FOLLOWING INFORMATION: THE IAB WAS INSERTED INTO THE PATIENT ON 8/27/98. AT APPROXIMATELY 0300 ON 8/31/98, THE NURSE NOTED THAT THE PRESSURE WAS LOW SO THE TECH CHECKED THE SYSTEM AND OBSERVED BLOOD IN THE HELIUM SUTTEL LINE. THE IAB WAS SWITCHED TO STANDBY MODE AND THE SURGEON WAS NOTIFIED. THE IAB WAS REMOVED APPROXIMATELY ONE HOUR LATER. THE PATIENT IS IN STABLE CONDITION. (ON 9/10/98, DATASCOPE ALSO RECEIVED THE MANDATORY MEDWATCH FORM FROM THE DISTRIBUTOR; UF/DIST REPORT NUMBER: FDA-34955-1998-010) ON 9/24/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: BLOOD WAS SEEN ENTERING THE HELIUM TUBING CONNECTION TO THE IAB. THE IAB WAS REMOVED AND ANOTHER WAS INSERTED. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT ON 8/31/97. THE PATIENT WENT ONTO EXPIRE ON 9/1/98 AT 9:03 PM. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 8/31/98 AND 9/24/98. [PATIENT'S CURRENT STATUS]: EXPIRED - RPT'D 9/24/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0283 05/01/00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN