BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET LINEAR 7.5 FR 40CC

    MDR report key: 6105555 · Received November 14, 2016

    Report

    Report Number
    MW5066050
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 14, 2016
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOTED BLOOD WITHIN THE IABP CATHETER TUBING SUSPECTED BALLOON RUPTURE. CATH. REMOVED AT BEDSIDE. NO PT. HARM NOTED. DATES OF USE: (B)(6) 2016. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO. EVENT ABATED AFTER STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749528 MAQUET LINEAR 7.5 FR 40CC IABP CATHETER AND BALLOON DSP MAQUET CARDIOVASCULAR, LLC 6084-00-0480-01U 3000036210

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention