BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINEAR 7.5 FR. 40CC IAB

    MDR report key: 3946217 · Received July 2, 2014

    Report

    Report Number
    2248146-2014-00192
    Event Type
    Death
    Date Received
    July 2, 2014
    Report Date
    June 15, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CONDITION RECEIVED: THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD FOUND ON THE EXTERIOR OF THE CATHETER. THE EXTENSION TUBING WAS ALSO RETURNED. ONE KINK WAS FOUND ON THE CATHETER TUBING APPROXIMATELY 76.5 CM FROM THE IAB TIP. PRODUCT EVALUATION: AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND NO LEAKS WERE DETECTED. THE IAB WAS PLACED ON THE CS300 PUMP AND PUMPED FOR TWO HOURS WHICH REPRESENTS ONE COMPLETE AUTOFILL CYCLE. THE IAB PUMPED NORMALLY AND NO ALARM SOUNDED FROM THE PUMP. CONCLUSION: THE REPORTED PROBLEM COULD NOT BE DUPLICATED DURING TESTING. WE ARE UNABLE TO DETERMINE WHEN THE KINK OCCURRED, HOWEVER, IF THE KINK OCCURRED DURING THE PROCEDURE IT COULD RESTRICT THE GAS FLOW THROUGH THE IAB WHICH COULD CAUSE THE REPORTED ALARM. A REVIEW OF THE DEVICE HISTORY DOES NOT INDICATE ANY LOT SPECIFIC ISSUES. (B)(4).

    Description of Event or Problem · 1

    PERMANENTLY MESSAGE "HIGH GAS LOSS" WITHOUT APPARENT CAUSE (NO DISLOCATION, NO RUPTURE). EXCHANGED TO ANOTHER DEVICE (CATHETER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385328 LINEAR 7.5 FR. 40CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 0684-00-0475 2615

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death