BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOSAVE

    MDR report key: 6015695 · Received October 10, 2016

    Report

    Report Number
    2249723-2016-00030
    Event Type
    Death
    Date Received
    October 10, 2016
    Date of Event
    September 10, 2016
    Report Date
    September 10, 2016
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION 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 SERVICE REPRESENTATIVE OBSERVED FAULT CODE # 37 (AUTOFILL FAILURE) AND THE REPORTED "GAS LOSS IN IAB CIRCUIT" ALARM HOWEVER WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. UNRELATED TO THE EVENT, IT WAS ALSO REPORTED THAT THE SERVICE REPRESENTATIVE REPLACED THE SAFETY DISK (PART #: 0202-00-0140) THAT WAS PAST DUE FOR REPLACEMENT PER THE PREVENTIVE MAINTENANCE BY FACTORY SPECIFICATION. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE MANUFACTURE EVALUATED THE FAULT LOGS AND CONCLUDED THAT THE RECORDED ALARMS ARE CONSISTENT WITH IAB CATHETER FAILURES HOWEVER IT IS NOT POSSIBLE TO EVALUATE THE IAB CATHETER BECAUSE THE CUSTOMER DISCARDED IT. THE MANUFACTURE ALSO EVALUATED PICTURES OF THE SOLID WHITE LINE/"WHITE BALK" AND DETERMINED THAT IS THE TIME IN STANDBY AREA THAT WILL APPEAR WHENEVER THE IABP HAS ASSISTED AND THEN HAS BEEN PUT IN STANDBY EITHER MANUALLY BY THE USER OR AUTOMATICALLY BY A HIGH PRIORITY ALARM AS REPORTED IN THE EVENT DESCRIPTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: PATIENT WAS PUT ON INTRA-AORTIC BALLOON PUMP (IABP) THERAPY DUE TO WEAK HEART CIRCULATION AFTER HAVING AORTO-CORONARY BYPASS SURGERY AND AORTIC VALVE REPLACEMENT. DURING IABP THERAPY, THE IABP GENERATED AN "AIR LEAKAGE" ALARM ("GAS LOSS IN IAB CIRCUIT"). ALONG WITH THE ALARM, A SOLID WHITE LINE/"WHITE BALK" APPEARED ON THE DISPLAY. THE CAREGIVERS CHECKED THE IAB WITH A SYRINGE TO MAKE SURE THAT WAS NO BLOOD OR LEAKS INSIDE THE IAB TUBING. THE CAREGIVERS ALSO VERIFIED THE IAB POSITION WITH X-RAY AND CHECKED THERE WERE NO BLOOD CLOTS BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE PATIENT¿S HEALTH STATUS DETERIORATED AND THE CAREGIVERS MADE THE DECISION TO STOP THERAPY. SHORTLY AFTER THE DISCONTINUATION OF THERAPY, THE PATIENT DIED. THE PATIENT DEATH PER THE CAREGIVERS, WAS NOT ATTRIBUTED TO THE IABP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665123 CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death