BEUDAMED
    FDA Adverse Event Death Summary report: N

    CS300

    MDR report key: 10607323 · Received September 30, 2020

    Report

    Report Number
    2249723-2020-01587
    Event Type
    Death
    Date Received
    September 30, 2020
    Date of Event
    June 6, 2020
    Report Date
    November 6, 2020
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE PATIENT HAS CHEST PAIN STARTED YESTERDAY NIGHT AND BECOME SEVERE UPON ARRIVAL TO HOSPITAL HE DEVELOP ACUTE PULMONARY EDEMA AND INTUBATED. HE ARRESTED WITH THREE EPISODES OF VENTRICULAR TACHYCARDIA (VT), SHOCKED, FOLLOWED BY PULSELESS ELECTRICAL ACTIVITY (PEA), CARDIOPULMONARY RESUSCITATION (CPR) DONE FOR 23 MINUTE. THEY SHIFTED THE PATIENT TO CATH LAB AND ALSO PERFORMED CPR THERE. PERCUTANEOUS CORONARY INTERVENTION (PCI) DONE TO MLAD (100% THROMBOTIC OCCLUSION) AND IT WAS SUCCESSFUL BUT PCI TO OM2 (100% THROMBOTIC OCCLUSION) FAILED TO ENSURE GOOD FLOW. IABP INSERTED IN CATH LAB AS THE PATIENT WAS IN CARDIOGENIC SHOCK. HE ARRESTED AGAIN AFTER ARRIVED TO CCU, CPR STARTED FOR MORE THAN 15 MINUTE AS ACLS PROTOCOL. RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS NOT ACHIEVED. THE CARDIOTHORACIC SURGERY TEAM WERE CONTACTED OR EMERGENCY EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) BUT WAS REFUSED AND HIS DEATH WAS DECLARED AT 13:16." IT WAS ALSO REPORTED THAT DURING USE ON THE PATIENT, THE BATTERY OF THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS DAMAGED AND OUT OF ITS SHAPE AND THAT THE END-USER BELIEVES THAT THE UNIT MAY HAVE CONTRIBUTED TO THE PATIENT 'S DEATH.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS IABP UNIT WAS REVIEWED AND NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT WERE NOTED. A GETINGE SERVICE TERRITORY MANAGER (STM) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE STM REPLACED NEW BATTERIES KIT AND IABP KEPT ON CHARGING AS PER PROCEDURE. THE FSE THEN PERFORMED ALL CALIBRATION, FUNCTIONAL AND SAFETY TESTS ON IABP, WHICH PASSED. THE IABP WAS RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE PATIENT HAS CHEST PAIN STARTED YESTERDAY NIGHT AND BECOME SEVERE UPON ARRIVAL TO HOSPITAL HE DEVELOP ACUTE PULMONARY EDEMA AND INTUBATED. HE ARRESTED WITH THREE EPISODES OF VENTRICULAR TACHYCARDIA (VT), SHOCKED, FOLLOWED BY PULSELESS ELECTRICAL ACTIVITY (PEA), CARDIOPULMONARY RESUSCITATION (CPR) DONE FOR 23 MINUTE. THEY SHIFTED THE PATIENT TO CATH LAB AND ALSO PERFORMED CPR THERE. PERCUTANEOUS CORONARY INTERVENTION (PCI) DONE TO MLAD (100% THROMBOTIC OCCLUSION) AND IT WAS SUCCESSFUL BUT PCI TO OM2 (100% THROMBOTIC OCCLUSION) FAILED TO ENSURE GOOD FLOW. IABP INSERTED IN CATH LAB AS THE PATIENT WAS IN CARDIOGENIC SHOCK. HE ARRESTED AGAIN AFTER ARRIVED TO CCU, CPR STARTED FOR MORE THAN 15 MINUTE AS ACLS PROTOCOL. RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS NOT ACHIEVED. THE CARDIOTHORACIC SURGERY TEAM WERE CONTACTED OR EMERGENCY EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) BUT WAS REFUSED AND HIS DEATH WAS DECLARED AT 13:16." IT WAS ALSO REPORTED THAT DURING USE ON THE PATIENT, THE BATTERY OF THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS DAMAGED AND OUT OF ITS SHAPE AND THAT THE END-USER BELIEVES THAT THE UNIT MAY HAVE CONTRIBUTED TO THE PATIENT 'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071244 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death BALLOON CATHETER| BALLOON CATHETER