BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID INT TYP B PLUG

    MDR report key: 14462815 · Received May 20, 2022

    Report

    Report Number
    2249723-2022-01196
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 27, 2022
    Report Date
    March 16, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FULL NAME OF THE EVENT SITE WAS SHORTENED DUE TO FIELD CHARACTER LIMIT; THE FULL NAME IS (B)(6). THE INITIAL REPORTER NAMED IN IS A GETINGE EMPLOYEE WHO HAS DIFFERENT CONTACT DETAILS FROM THAT OF THE EVENT SITE. A CONTACT PHONE AT THE EVENT SITE IS (B)(6). TESTING OF ACTUAL/SUSPECTED DEVICE: A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP AND OPENED THE HELIUM CYLINDER CONTAINING ABOUT 2000 PSI IN HYBRID MODE. AFTER THAT, WHEN A RUNNING TEST WAS CONDUCTED FOR 3 DAYS, THE REMAINING AMOUNT OF HELIUM WAS REDUCED TO ABOUT 1100 PSI. TO FIX THE ISSUE, THE FSE REPLACED THE HIGH PRESSURE REGULATOR AND THE HIGH PRESSURE TRANSDUCER, AND PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    IN ORDER TO FIX THE REPORTED ISSUE, THE FSE REPLACED THE HIGH PRESSURE REGULATOR (0103-00-0637) AND THE HIGH PRESSURE TRANSDUCER (0682-00-0092-01), AND PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE UNIT WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE FOLLOWING INVESTIGATIONS WERE PERFORMED BY TECHNICIAN OF THE MAQUET NATIONAL REPAIR CENTER (NRC) FOR THE RETURNED PARTS; HIGH PRESSURE REGULATOR AND THE HIGH PRESSURE TRANSDUCER: THE HIGH PRESSURE HELIUM REGULATOR PART NUMBER 0103-00-0637 S/N (B)(6) WAS OBSERVED PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION P WITH NO VISUAL DAMAGE. THE NATIONAL REPAIR CENTER INSTALLED THE HIGH PRESSURE HELIUM REGULATOR INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER CA204345L1 AND VERIFY THE LEAK AS PER FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION C AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION P. THE HIGH PRESSURE HELIUM REGULATOR WAS TESTED FOR APPROXIMATELY 6 HOUR PERIOD RESULTING IN A LEAK IN THE REGULATOR. HIGH PRESSURE HELIUM REGULATOR WOULD NOT HOLD PRESSURE AS PER THE SPECIFICATIONS. (THE X4 ¿ EXTERNAL HELIUM TANK PRESSURE. READING SHOULD NOT DROP BY MORE THAN 20 PSI IN THE 5 MINUTE PERIOD.) FAILED TESTING OF 74 PSI IN A 5 MINUTE PERIOD. HIGH PRESSURE HELIUM REGULATOR WILL BE HELD IN THE NRC PER PROCEDURE NUMBER 0002-07-D008 REVISION AJ. THE PRESSURE TRANSDUCER 3500 PART NUMBER 0682-00-0092-01 S/N (B)(6) WAS OBSERVED PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION P WITH NO VISUAL DAMAGE. THE NRC INSTALLED THE PRESSURE TRANSDUCER 3500 INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND COULD NOT VERIFY THE LEAK AS PER FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION C AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION P. TRANSDUCER TESTED TO FACTORY SPECIFICATIONS AND PASSED ALL TESTES. PRESSURE TRANSDUCER 3500 WILL BE HELD IN THE NRC PER PROCEDURE NUMBER 0002-07-D008 REVISION AJ.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE-DELIVERY INSPECTION, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A HELIUM LEAK. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PRE-DELIVERY INSPECTION PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A HELIUM LEAK. THE FSE ALSO STATED THAT HE OPENED THE HELIUM CYLINDER, WHICH CONTAINED ABOUT 2000 PSI IN HYBRID MODE. THEN, WHEN A RUNNING TEST WAS CONDUCTED FOR 3 DAYS, THE REMAINING AMOUNT OF HELIUM WAS REDUCED TO ABOUT 1100 PSI. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369112 CARDIOSAVE HYBRID INT TYP B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-65 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown