BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUGN/

    MDR report key: 19704453 · Received July 9, 2024

    Report

    Report Number
    2249723-2024-02786
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 20, 2024
    Report Date
    November 8, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G3, G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H10, H11. CORRECTED FIELDS: D4 (UDI). THE FSE THAT ENCOUNTERED THE ISSUE STATED THAT THE PRESSURE SENSOR AND THE SOLENOID VALVE OF THE HELIUM FILLING SYSTEM WERE DEFECTIVE. THE FSE REPLACED THE HELIUM FILLING PNEUMATIC BLOCK (0997-00-0565). THE FSE PERFORMED CALIBRATIONS PER FACTORY PROCEDURE. OPERATIONAL TESTS WERE CARRIED OUT WITH POSITIVE RESULTS. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0997-00-0565 ASSY. HELIUM RESERVOIR SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF FAILURE OF BALLOON SELF FILLING. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0997-00-0565 ASSY. HELIUM RESERVOIR SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE HELIUM RESERVOIR TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION E AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. THE FAT DEPT. BOOTED THE CARDIOSAVE TEST FIXTURE IN THE CLINICAL MODE AND PERFORMED AN AUTOFILL. THE CARDIOSAVE PERFORMED AN AUTOFILL WITH NO TROUBLE FOUND. THE FAT DEPT. THEN PROCEEDED TO PULL THE BALLOON FROM THE PIM, HAD IT ALARM, THEN PERFORMED ANOTHER AUTOFILL. THE CARDIOSAVE AUTOFILLED WITH NO TROUBLE FOUND. THE FAT DEPT. PERFORMED AN AUTOFILL FOUR MORE TIMES CONSECUTIVELY. THE CARDIOSAVE AUTOFILLED TO FACTORY SPECIFICATIONS EACH TIME. THE FAT DEPT. COULD NOT REPLICATE THE COMPLAINT OF FAILURE OF BALLOON SELF FILLING. THE HELIUM RESERVOIR PASSED TESTING. RETAINING THE HELIUM RESERVOIR IN THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D008 REV. AR.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A GETINGE FIELD SERVICE ENGINEER THAT WHILE CHECKING THE DEVICE BEFORE UPDATING THE SOFTWARE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS FAILING TO FILL THE BALLOON.  THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459846 CARDIOSAVE HYBRID W/ E/F PLUGN/ SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown