BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRA AORTIC BALLOON

    MDR report key: 4039951 · Received August 19, 2014

    Report

    Report Number
    2248146-2014-00335
    Event Type
    Death
    Date Received
    August 19, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 21, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL, THEREFORE A ROOT CAUSE COULD NOT BE IDENTIFIED. IF ADDITIONAL INFO IS RECEIVED OR THE DEVICE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED. SINCE THE DEVICE INFO WAS NOT AVAILABLE, THE CUSTOMER SHIPPING HISTORY WAS REVIEWED TO DETERMINE THE MOST LIKELY LOT(S) INVOLVED IN THIS EVENT. A LOT HISTORY REVIEW WAS PERFORMED FOR THOSE LOTS. NO NON-CONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS STATED THEY DID HAVE SOME ARTERIAL LINE ISSUES INITIALLY, BUT THEN COULD NOT GET THE ARTERIAL-LINE TO ZERO ON THEIR TRANSPORT. THEY PUT IT BACK ON THE FT. HAMILTON PUMP AND IT WOULD ZERO AND GOT INDICES FOR A FEW MINUTES, BUT THEN THE NUMBERS DISAPPEARED. THE PUMP WAS STILL PUMPING, JUST NO INDICES PRESENT. WHEN PT GOT TO THE (B)(6) HOSPITAL A NEW IAB WAS INSERTED. NO ISSUES OR EFFECTS ON PT. FOLLOW UP WAS REPORTED: THE LUMEN IS THE ARTERIAL LINE THAT WE CONNECT TO A FLUSH SYSTEM AND TRANSDUCER TO ZERO. THE PUMP WAS WORKING FINE, THE RECEIVING HOSPITAL CHANGED OUT THE IAB BECAUSE THE LUMEN WAS CLOTTED WHEN THEY GOT THE PT, BUT PUMP WAS PUMPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498915 INTRA AORTIC BALLOON DSP DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death