BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21783926 · Received April 7, 2025

    Report

    Report Number
    2249723-2025-0001622
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 24, 2025
    Report Date
    December 16, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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, E3, G1(CONTACT PERSON ¿ MFG SITE), G3, G6, H2,H3, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS,COMPONENT CODE), H1. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0997-00-0565 WITH A REPORTED UNIT FAILURE OF A HELIUM LEAK. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE OXIDIZED IN SOME AREAS. SEE ATTACHMENT. THE FAT INSTALLED THE PART IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. CONFIRMED THE REPORTED HELIUM LEAK. NO ROOT CAUSE CAN BE IDENTIFIED. PROBABLE IS THE OXIDATION ON THE PART. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER (B)(6) REV. AU. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE REPLACED THE HELIUM RESERVOIR ASSEMBLY (0997-00-0565). THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: B5, H6 (INVESTIGATION FINDINGS).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD EXCESSIVE LEAK OF THE HELIUM. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569951 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown