BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINEAR 7.5 FR. 40CC IAB

    MDR report key: 3931246 · Received June 26, 2014

    Report

    Report Number
    2248146-2014-00115
    Event Type
    Death
    Date Received
    June 26, 2014
    Date of Event
    March 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CONDITION RECEIVED: THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE EXTERIOR OF THE CATHETER. NO BLOOD WAS OBSERVED INSIDE THE BALLOON, CATHETER, OR EXTRACORPOREAL TUBING. ONE KINK WAS FOUND NEAR THE Y-FITTING APPROX 76.2CM FROM THE 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 KINK WAS INDUCED AND THE IAB PUMPED NORMALLY AND NO ALARM SOUNDED FROM THE PUMP. CONCLUSION: THE RETURNED PRODUCT WAS TESTED AND REPORTED ALARMS COULD NOT BE DUPLICATED. (B)(4).

    Description of Event or Problem · 1

    "BLOOD BACK" ALARM AND "CHECK IAB CATHETER" ALARM SOUNDED AFTER 10 MINUTES. ANOTHER PUMP WAS USED AND LINEAR CATHETER WAS REPLACED. PT HAD PREVIOUS IAB INSERTED VIA AORTA. THIS IAB WAS REMOVED TO CLOSE PT CHEST. PT DESTABILIZED. NEW IAB INSERTED INTO AORTA. IABP ALARM: SYSTEM LEAK AND RAPID GAS LOSS. CHANGED IABP. ALARM PERSISTED. CHANGED OUT IAB WORKED FINE. PT DIED 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374851 LINEAR 7.5 FR. 40CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP 0684-00-0475 2554

    Patients

    Seq Age Sex Outcome Treatment
    1 Death