BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 39165 · Received September 20, 1996

    Report

    Report Number
    2242850-1996-00063
    Event Type
    Injury
    Date Received
    September 20, 1996
    Date of Event
    April 14, 1996
    Report Date
    August 26, 1996
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT ON 4/14/96 AT APPROX 0515 FOR INTRACTABLE ANGINA, AWAITING CORONARY ARTERY BYPASS GRAFT SURGERY. AN ALARM SOUNDED FROM THE PUMP. THE INITIAL NURSING ASSESSMENT WAS: DECREASE AUGMENTATION, DECREASE AFTERLOAD, NO LINE KINKS, NO BLOOD IN TUBING. THE IAB WAS REFILLED AND IABP CONTINUED BUT THE ALARM SOUNDED AGAIN. THEN AT 1145 THE SAME DAY, THE PT HAD ABDOMINAL PAIN AND PINK FLUID WAS NOTED IN THE TUBING. (CO RECEIVED THIS REPORT VIA THE MANDATORY MEDWATCH FORM FROM THE USER FACILITY; UF/DIST REPORT #2600-320000-1996-0015). THE IAB WAS NOT RETURNED TO CO FOR EVALUAITON. THE IAB WAS DISCARDED BY THE FACILITY. ANOTHER IAB WAS NOT INSERTED BECAUSE A HEMATOMA DEVELOPED AT THE INSERTION SITE AFTER THE BALLOON WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other