BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 17594999 · Received August 22, 2023

    Report

    Report Number
    2249723-2023-03771
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    August 13, 2023
    Report Date
    May 10, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567112541
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO EVALUATE THE IABP BECAUSE THE CUSTOMER REFUSED TO REPAIR THE UNIT AND INSTEAD PURCHASED ANOTHER UNIT BECAUSE THE UNIT WAS SCRAPPED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT SHUT DOWN. UNIT CHANGES TO ANOTHER CS 300 UNIT. THE CONTRAPULSOR WAS ON DURING THE LAST DAY RANDOMLY ALARMED BALLOON INFLATION FAILURE, BUT HAD RESTARTED WITHOUT PROBLEMS FROM THE MANUAL INFLATION BUTTON WHEN PRESSED. AROUND 11:20 THE PATIENT SLIGHTLY BENT HIS LEG (LESS THAN 30 DEGREES), AS A RESULT OF WHICH THE DEVICE GAVE THE SAME ALARM. THIS TIME, THE BALLOON COULD NO LONGER BE FILLED MANUALLY BY PRESSING THE BUTTON, BUT "SYSTEM FAILURE" TEXTS. TRIED RESTARTING THE DEVICE TWICE BY TURNING OFF THE POWER, BUT IT DIDN'T HELP, THE RESULT WAS THE SAME "SYSTEM FAILURE"- AD. WHEN THE SITUATION STARTED, THE EQUIPMENT CUSTODIAN HAD BEEN ASKED TO GET A NEW COUNTERPULSATOR FROM THE PERFUSION WAREHOUSE OF THE OPERATING ROOM IN CASE THE OLD DEVICE NO LONGER WORKS. THANKS TO THIS, THE PATIENT COULD USE THE NEW DEVICE IN A FEW MINUTES. WHILE THE PATIENT DID NOT HAVE A FUNCTIONING CONTRAPULSOR, HE HAD TO START A NORADRENALINE INFUSION AND ALBUMIN FILLING TO BRING THE BLOOD PRESSURE LEVEL TO MAINTAIN. THE SITUATION WAS CORRECTED WHEN THE NEW COUNTERPULSATOR WAS CONNECTED AND THE DEVICE WAS STARTED. THE REPLACED COUNTERPULSATOR STILL HAD PLENTY OF HELIUM IN THE BOTTLE AND THE POWER CORD IN THE WALL NOT IN THE POWER CORD OF THE BALLOON VISIBLE DAMAGE. AFTER RESTARTING THE DEVICE CONTROL KEYS DID NOT WORK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT SHUT DOWN. UNIT CHANGES TO ANOTHER CS 300 UNIT. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50441 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-55 10607567112541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O