BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21431985 · Received February 21, 2025

    Report

    Report Number
    2249723-2025-0000821
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Report Date
    April 25, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1: INITIAL REPORTER: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELD: H6(INVESTIGATION CONCLUSIONS).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND CONFIRMED THE REPORTED FAILURE. THE FSE NARROWED DOWN THE ISSUE TO THE HIGH PRESSURE REGULATOR (0103-00-0637 )WHICH FSE REPLACED. IDENTIFIED REPLACED REGULATOR BACKED OUT ON THE BOTTOM MORE THAN THE NEW REGULATOR. AFTER FSE REPLACED HIGH PRESSURE REGULATOR, THE UNIT SUCCESSFULLY COMPLETED A SIMULATED TREATMENT WITH TESTING CATHETER AND TRAINER WITHOUT ISSUE, AS WELL AS FULL SYSTEM CHECKOUT. PERFORMED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT WAYNE, NJ: THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: PN: 0103-00-0637 REV F, SN: (B)(6) HELIUM REGULATOR. THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF LEAK HIGH PRESSURE REGULATOR. PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND FOUND THE PORT WAS DAMAGED, WHERE THE TRANSDUCER IS INSTALLED. PLEASE SEE ATTACHED PICTURE. DUE TO THE PORT DAMAGED AND O-RING WILL NOT SIT PROPERLY INTO THE PORT WHERE TRANSDUCER INSTALL, THIS PART CANNOT BE INVESTIGATED WITH CARDIOSAVE TEST FIXTURE. THIS PROBABLE THE CAUSE OF LEAK. RETAINING HELIUM REGULATOR IN THE FAT DEPT. AS PER PROCEDURE 0002-07-D008 REV AT. THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE IS PHYSICAL DAMAGE AND EXTERNAL FORCE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING PART OF DAILY CHECKS THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HIGH PRESSURE REGULATOR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666646 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