BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 34 CC. IAB

    MDR report key: 206351 · Received January 13, 1999

    Report

    Report Number
    2248146-1998-01184
    Event Type
    Injury
    Date Received
    January 13, 1999
    Date of Event
    December 18, 1998
    Report Date
    December 24, 1998
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE IAB DID NOT MALFUNCTION. THE PT HAD A MASSIVE PULMONARY HEMORRHAGE. THE IAB WAS NOT RETURNED TO DATASCOPE. ON 12/30/1998, THE FOLLOWING INFORMATION WAS REPORTED TO DATASCOPE: THE PT WAS ON HEPARIN AND EXPERIENCED PULMONARY HEMORRAGE UPON ARRIVAL TO CRITICAL CARE UNIT AFTER CARDIAC CATHERIZATION AND IABP INSERTION. THE PT EXPIRED ON 12/19/1998. BRONCHOSCOPY SHOWED GENERALIZED BLEEDING FROM BOTH LUNGS. NO LOCALIZED BLEED WAS FOUND. ON 1/12/1999, DATASCOPE WAS NOTIFIED THAT THE PT'S DEATH WAS NOT ATTRIBUTED TO BALLOON THERAPY. EVENT COMPLICATION: MASSIVE PULMONARY HEMORRHAGE - REPORTED 12/24/1998. PT'S CURRENT STATUS: EXPIRED REPORTED 12/24/1998.

    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 CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| O