BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 18922046 · Received March 18, 2024

    Report

    Report Number
    2249723-2024-01133
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    March 8, 2024
    Report Date
    October 17, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    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 GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND WAS NOT ABLE TO DUPLICATE THE CRITICAL ALARMS. FSE FOUND OUT GAS LOSS ALARM AND AUGMENTATION RELATED ALARMS IN THE LOGS. FSE REPLACED EXECUTIVE PROCESSOR BOARD AS PREVENTIVE MAINTENANCE. FSE FOUND THAT BP CONNECTOR ON FRONT END BOARD IS DAMAGED AND FSE RESOLVED THE ISSUE BY REPLACING FRONT END BOARD. FSE CALIBRATED AND THEN TESTED THE SAFETY AND FUNCTIONALITY AS PER FACTORY SPECIFICATIONS AND IABP WAS THEN RETURNED TO CUSTOMER FOR CLINICAL USE. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. PLEASE REFER TO THE ROOT CAUSE EVALUATION FIELD FOR DETAILS. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN 0670-00-0770 REV. C, SN (B)(6), PN 0670-00-0769 REV. F, SN (B)(6) PARTS WERE RECEIVED WITH A REPORTED FAILURE OF CRITICAL ALARMS AND A DAMAGED BP PORT ON FRONT END BOARD. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND PN 0670-00-0769 TO BE DAMAGED AT THE BP PORT. ISSUE CONFIRMED. THE FAT INSTALLED PN 0670-00-0770 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. NO ISSUE CONFIRMED. THIS REVISION IS OBSOLETE AND NO LONGER ABLE TO BE TESTED BY A SUPPLIER. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER (B)(4). THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H5).

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A ROUTINE CHECK PERFORMED BY THE CUSTOMER, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SHOWED CRITICAL ALARMS. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182071 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