BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 16371171 · Received February 14, 2023

    Report

    Report Number
    2249723-2023-01109
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    February 2, 2023
    Report Date
    April 10, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL FIELDS: E1(EVENT SITE POSTAL CODE: (B)(6)). ADDITIONAL INFORMATION: CONTACT PERSON (NAME: (B)(6), EMAIL ADDRESS: (B)(6)). IT WAS REPORTED THAT PREVENTIVE MAINTENANCE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) GETINGE FIELD SERVICE ENGINEER (FSE) CONFIRMED HELIUM PRESSURE HELIUM REGULATOR WAS LEAKING AND THERE WAS A HISSING NOISE THIS HAPPENED WHEN HELIUM BOTTLE WAS REPLACED. HELIUM REGULATOR (0103-00-0637) WAS REPLACED AND PERFORMED PM AND SAFETY CHECKS. REPAIR PERFORMED AND UNIT CLEARED FOR CLINICAL USE AND RETURNED TO CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 0

    FAT HAS DONE FAILURE INVESTIGATION ON THE DEFECTIVE PARTS RETURNED. IT WAS REPORTED THAT PREVENTIVE MAINTENANCE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) GETINGE FIELD SERVICE ENGINEER (FSE) CONFIRMED HELIUM PRESSURE HELIUM REGULATOR WAS LEAKING AND THERE WAS A HISSING NOISE THIS HAPPENED WHEN HELIUM BOTTLE WAS REPLACED. HELIUM REGULATOR (0103-00-0637) WAS REPLACED AND PERFORMED PM AND SAFETY CHECKS. REPAIR PERFORMED AND UNIT CLEARED FOR CLINICAL USE AND RETURNED TO CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE HELIUM REGULATOR ASSOCIATED WITH THIS COMPLAINT. THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF HELIUM LEAK AND HISSING NOISE. PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND OBSERVED DAMAGE PORT WHERE THE TRANSDUCER IS INSTALLED AND FOREIGN SUBSTANCE INSIDE THE PORT. PLEASE SEE ATTACHED PICTURE OF DAMAGED PORT. DUE TO THIS DAMAGED PORT AND FOREIGN SUBSTANCE INSIDE THE PORT THE FAT DEPT. CANNOT BE INVESTIGATED FURTHER THIS PART AND THE O-RING WILL NOT SIT PROPERLY INTO THE PORT AND THIS PROBABLY CAUSE A LEAK. RETAINING HELIUM REGULATOR IN THE FAT DEPT. AS PER PROCEDURE (B)(4) REV AQ. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HI PRESSURE HELIUM REGULATOR WAS LEAKING AND THERE WAS A HISSING NOISE . THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) DURING PM, THE HI PRESSURE HELIUM REGULATOR WAS LEAKING AND THERE WAS A HISSING NOISE .

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809880 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose