BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23015264 · Received September 10, 2025

    Report

    Report Number
    2249723-2025-0003788
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 22, 2025
    Report Date
    November 13, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, E1 ( INITIAL REPORTER, EVENT SITE EMAIL), E2, G3, G6, H2, H11. CORRECTED FIELDS: H6 (INVESTIGATION FINDINGS, COMPONENT CODES).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSION), H11. CORRECTED FIELDS - D7A. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED PARTS 0997-00-0565 AND 0103-00-0637 WITH A REPORTED UNIT FAILURE OF A HELIUM LEAK. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND PN 0997-00-0565 TO BE IN GOOD CONDITION. PN 0103-00-0637 WAS FOUND TO HAVE A DAMAGED HELIUM NOZZLE PORT. THIS DAMAGE WOULD CAUSE HELIUM TO LEAK FROM THE SYSTEM. PROBABLE ROOT CAUSE FOR THIS IS USER ERROR. THE FAT INSTALLED 0997-00-0565 IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. NO FAILURE CONFIRMED FOR THIS PART. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT. ROOT CAUSE 1 (DEFECTIVE/SUPPLIER): CONTAMINANTS MAY NOT BE FULLY REMOVED DURING THE SUPPLIER CLEANING PROCESS OF THE CARDIOSAVE HIGH PRESSURE REGULATOR (0103-00-0637). ROOT CAUSE 2 (PROCEDURE / REQUIREMENT(S) ¿ GAP): CARDIOSAVE SERVICE MANUAL DOES NOT INCLUDE A REQUIREMENT TO REPLACE THE QUICK DISCONNECT MALE FITTING O-RING AS PART OF THE ANNUAL PREVENTIVE MAINTENANCE. A GETINGE FIELD SERVICE ENGINEER EVALUATED THE UNIT AND SUCCESSFULLY COMPLETED A SIMULATED TREATMENT UPON INITIALLY TESTING UNIT WITH TESTING CATHETER AND SIMULATOR WITHOUT ISSUE. COMPLETED HELIUM LEAK TESTS ON XCARC AND X5. IDENTIFIED X4 DROPPING STEADILY WHEN CLOSING THE TANK, FAR EXCEEDING 20 PSIG AFTER 5 MINUTES. WITH CONSOLE OUT OF THE CART, OBSERVED X5 DROPPING 4 PSIG IN ABOUT 4 MINUTES, THUS FAILING THE LEAK TEST. GIVEN AFOREMENTIONED READINGS OUT OF TOLERANCE, REPLACED HIGH PRESSURE REGULATOR (0103-00-0637), (0997-00-0565) HELIUM ASSY, AS WELL AS FILL MANIFOLD. POST AFOREMENTIONED REPLACEMENTS, SUCCESSFULLY COMPLETED, A FULL SYSTEM CHECKOUT WITHOUT ISSUES. NOTHING UNUSUAL IDENTIFIED IN THE LOGS, ATTACHED FOR REFERENCE. THE UNIT CALIBRATED AND PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD HELIUM LEAK. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488957 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.