BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 8290016 · Received January 30, 2019

    Report

    Report Number
    2249723-2019-00150
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    January 7, 2019
    Report Date
    April 5, 2019
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECTED FAILED OOB CARDIOSAVE UNIT WAS RETURNED FROM THE FIELD TO GETINGE'S NATIONAL REPAIR CENTER FOR EVALUATION. UPON EVALUATION BY THE NRC TECHNICIAN, THE REPORTED ISSUE "LARGE HELIUM LEAK AT FILL MANIFOLD" WAS NOT REPRODUCED. MULTIPLE HELIUM LEAK TESTS WERE PERFORMED, AND THE HELIUM LEAK TESTS PASSED WITH AN AVERAGE LEAK RATE OF 10 MMHG AFTER 5 MINUTE PERIODS. TESTING WAS DONE WITH A FULL PRESSURE HELIUM TANK WHICH WAS CLOSED AT THE TANK'S SHUT OFF VALVE; THE IABP UNIT WAS FURTHER TESTED FOR SEVERAL DAYS WHILE PERIODICALLY CHECKING HELIUM TANK PRESSURE - NO ISSUES WERE OBSERVED. THE IABP WAS ABLE TO PASS ALL THE LEAK AND PERFORMANCE TESTS. THE TECHNICIAN THEN PERFORMED PREVENTIVE MAINTENANCE (PM), FUNCTIONAL AND SAFETY CHECKS PER SERVICE MANUAL AND ALL TESTS PASSED PER FACTORY SPECIFICATIONS. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RECEIVED A REPLACEMENT PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WE WILL REPORT ACCORDINGLY WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INSTALLATION OF A BRAND NEW CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP), THE IABP HAD A SIGNIFICANT LEAK AT THE FILL MANIFOLD. THIS IS AN OUT-OF-BOX (OOB) FAILURE. THE CUSTOMER DECLINED RECEIPT OF THE IABP UNIT. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INSTALLATION OF A BRAND NEW CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP), THE IABP HAD A SIGNIFICANT LEAK AT THE FILL MANIFOLD. THIS IS AN OUT-OF-BOX (OOB) FAILURE. THE CUSTOMER DECLINED RECEIPT OF THE IABP UNIT. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS REVIEWED AND NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT WERE NOTED. THE GETINGE FIELD SERVICE ENGINEER (FSE) RE-CRATED THE IABP UNIT IN THE ORIGINAL PACKING AND SHIPPED IT TO GETINGE MANUFACTURING IN (B)(4) FOR REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WE WILL REPORT ACCORDINGLY WHEN IT BECOMES AVAILABLE. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INSTALLATION OF A BRAND NEW CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP), THE IABP HAD A SIGNIFICANT LEAK AT THE FILL MANIFOLD. THIS IS AN OUT-OF-BOX (OOB) FAILURE. THE CUSTOMER DECLINED RECEIPT OF THE IABP UNIT. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81306 CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1