BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 183810 · Received August 18, 1998

    Report

    Report Number
    2248146-1998-00939
    Event Type
    Malfunction
    Date Received
    August 18, 1998
    Date of Event
    August 10, 1998
    Report Date
    August 11, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-00996) THE IAB WAS INSERTED INTO THE PATIENT ON 7/17/98 AT 5:15 P.M. ON 8/10/98 AT 5:55 P.M., THE IAB LEAKED AND THE IAB WAS REMOVED. NO SECOND IAB WAS INSERTED. ON 8/28/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE IABP ALARMED "BLOOD DETECTED". BLOOD WAS NOTED TO HAVE ENTERED THE PUMP PNEUMATICS. THE TUBING CONNECTIONS WERE ALSO NOTED TO BE RED TINGED. THERE WAS NOT ANY NOTED "STREAKING" OF THE CONNECTION TUBING AND THERE HAD NOT BEEN ANY PREVIOUS ALARMS. THE ALARM WAS REPORTED TO THE DOCTOR. THE BALLOON WAS DISCONNECTED AND THE IAB WAS REMOVED. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE IN ICU WITH CHRONIC HEART FAILURE AND CMP. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 8/11/98 AND 8/28/98. [PATIENT'S CURRENT STATUS]: STABLE - REPORTED 8/11/98.

    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. 0684-00-0269 05/02/00

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR