BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KONTRON INSTRUMENTS

    MDR report key: 16274 · Received February 4, 1994

    Report

    Report Number
    16274
    Event Type
    Injury
    Date Received
    February 4, 1994
    Date of Event
    December 6, 1993
    Report Date
    December 20, 1993
    Manufacturer
    KONTRON INSTRUMENTS, INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED ON 12/2/93 FOR TOTAL LEFT HIP REPLACEMENT. THE EVENING OF 12/2/93 THE PATIENT COMPLAINED OF SHORTNESS OF BREATH AND CHEST TIGHTNESS. CARDIAC CATH BALLOON ANGIOPLASTY PERFORMED ON 12/5/93. ON 12/6/93 AORTIC BALLOON PUMP (ABP) RUPTURE WAS SUSPECTED. SMALL AMOUNT OF BLOOD WAS DETECTED IN THE SHEATH OF THE SWAN-GANZ WAS LEAKING INTO THE IABP CATHETER TUBING. ON 12/6/93 THE ABP WAS REPLACED. AFTER SHOWING IMPROVEMENT IN THE DAYS FOLLOWING THE PROCEDURE, ON 12/10/93, THE PATIENT EXPIRED FOLLOWING AN EPISODE OF REGULATORY DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KONTRON INSTRUMENTS INTRA AORTIC BALLOON PUMP DSP KONTRON INSTRUMENTS, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening| R 12/2/93 TOTAL LEFT HIP REPLACEMENT