BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 185569 · Received September 2, 1998

    Report

    Report Number
    2248146-1998-00993
    Event Type
    Malfunction
    Date Received
    September 2, 1998
    Date of Event
    August 21, 1998
    Report Date
    August 25, 1998
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01056) AFTER IABP FOR SEVERAL DAYS, THE IAB LEAKED. ON 9/17/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE PATIENT HAD BEEN WEANED TO 1:3 TIMING TO 1:1. THE ORDER WAS CARRIED OUT AND SHORTLY AFTER THE TIMING CHANGE OCCURRED, AN ALARM FOR "CHECK IAB CATHETER" SOUNDED. BLOOD WAS THEN NOTED IN THE TUBING. THE IAB WAS REMOVED AND ANOTHER WAS NOT INSERTED. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT ON 8/21/98. THE PHYSICIAN HAD BEEN CONTEMPLATING WEANING THE PATIENT PRIOR TO THE LEAK. THE PATIENT WAS TRANSFERRED OUT OF ICU TO THE GENERAL MEDICAL FLOOR ON 8/27/98. THE PATIENT REMAINED UNRESPONSIVE SINCE ARRESTING IN THE CAR PRIOR TO HOSPITAL ADMISSION. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 8/25/98 AND 9/17/98. [PATIENT'S CURRENT STATUS]: UNRESPONSIVE -RPT'D 9/17.

    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 0684-00-0269 05/02/00

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR