BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID INTRA-AORTIC PUMP

    MDR report key: 3897578 · Received May 15, 2014

    Report

    Report Number
    2249723-2014-00344
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE HISTORY RECORD (DHR) FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE WERE NO NON-CONFORMANCES IN THE DHR RELATED TO THE REPORTED EVENT. THE COMPANY REPRESENTATIVE OBSERVED A WHITE SUBSTANCE, MOST LIKELY SALINE, AROUND THE CONNECTOR WHICH CONNECTS THE DISPLAY MODULE TO THE CONSOLE. BY MOVING THIS, IT IS POSSIBLE TO GET THE UNIT TO GENERATE AN ERROR AND RESET. THE DISPLAY SOMETIMES GOES BLANK AND THE IABP GET A HIGH PITCH ERROR TONE. THE COMPANY REPRESENTATIVE REPLACED BACKPLANE TO COILED CD (PART NUMBER 0012-00-1796), A GASKET (PART NUMBER 0345-00-0201) AND COILED CORD CABLE (0012-00-1801). THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THIS IABP HAD A PREVIOUS INCIDENT WITH A SALINE SPILL AND THE SAFETY DISK WAS REPLACED. PERFORMED ALL THE FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE PUMP WAS RETURNED TO THE CUSTOMER. THE REPLACED PARTS ARE BEING REQUESTED TO BE RETURNED TO THE MANUFACTURING FACILITY IN (B)(4) FOR EVALUATION. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHILE TRANSPORTING PATIENT TO THE AMBULANCE, THE CARDIOSAVE WHILE STATE MOUNTED IN THE CART SWITCHED OFF. THE CUSTOMER PRESSED THE POWER ON/OFF BUTTON, THE UNIT POWERED ON AGAIN AND APPEARED FINE, THEY PROCEEDED WITH THE TRANSPORT BUT WHEN REACHING THE OTHER HOSPITAL AND UNLOADING THE UNIT IT SWITCHED OFF AGAIN. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292566 CARDIOSAVE HYBRID INTRA-AORTIC PUMP INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR