BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT DL 9.5 FR. 40CC. IAB

    MDR report key: 181653 · Received August 1, 1998

    Report

    Report Number
    2248146-1998-00864
    Event Type
    Death
    Date Received
    August 1, 1998
    Date of Event
    June 25, 1998
    Report Date
    July 24, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-00912) THE IAB WAS INSERTED INTO THE PATIENT ON 6/21/98. ON 6/25/98, THE "BLOOD DETECT IAB" ALARM SOUNDED FROM THE PUMP. THE PUMP WAS SHUT OFF AND THE PATIENT WAS MADE A DNR. THE PATIENT WENT ON TO EXPIRE. IT WAS UNKNOWN IF THE EVENT CONTRIBUTED TO THE DEATH. ON 7/28/98, DATASCOPE RECEIVED THE MANDATORY MEDWATCH FORM FROM THE USER-FACILITY; UF/DIST REPORT NUMBER: 1000070000-1998-0001 AND THE FOLLOWING INFORMATION WAS REPORTED: AFTER IABP FOR 81.5 HOURS, THE "BLOOD DETECTED IN IAB" ALARM SOUNDED FROM THE PUMP. DRIED POWDERED BLOOD PARTICLES WERE NOTED IN THE EXTRA CORPORAL TUBING OF THE INTRA-AORTIC BALLOON CATHETER INDICATIIVE OF A LEAK. BALLOON PUMPING WAS HALTED AND THE PHYSICIAN WAS NOTIFIED. THE PATIENT WAS PLACED ON DNR STATUS. THE FAMILY DID NOT WISH WITHDRAWAL OF LIFE SUPPORT EQUIPMENT. WITHIN 25 MINUTES, THE PATIENT EXPIRED. DATASCOPE WAS NOTIFIED THAT THE FACILITY WOULD NOT RELEASE THE IAB AT THIS TIME. ON 8/11/98, DATASCOPE WAS INFORMED BY THE USER FACILITY THAT THE CORRECT USER FACILITY/DISTRIBUTOR REPORT NUMBER IS 1000070000-1998-0002. ON 8/21/98, DATASCOPE WAS NOTIFIED THAT THE IAB WOULD BE RETURNED FOR EVALUATION. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 7/24/98; PATIENT DEATH - REPORTED 7/28/98. [PATIENT'S CURRENT STATUS]: EXPIRED - RPT'D 7/24/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0321 06/04/00

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death