BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19667548 · Received July 3, 2024

    Report

    Report Number
    2249723-2024-02717
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 13, 2024
    Report Date
    October 3, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    CORRECTED FIELDS: D4. A GETINGE FIELD SERVICE ENGINEER (FSE) REPORTED THAT THEY REPLACED THE FIBER OPTIC EXTENSION CABLE CONNECTOR. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO CUSTOMER. THE FSE ALSO USED THE PM SCREW KIT AND BUNA O-RING. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0012-00-1562 E SERIAL NUMBER 16 36 RAM WITH A REPORTED UNIT FAILURE OF A DAMAGED FIBER OPTIC CONNECTOR. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED VISUAL INSPECTION OF THE PART RECEIVED PART NUMBER 0012-00-1562 E SERIAL NUMBER 15 06_RAM CATHETER CONNECTOR AND FOUND THAT THE BLUE RECEPTACLE HOUSING OF THE FIBER OPTIC CONNECTOR IS BROKEN. DUE TO THIS DAMAGE. THIS PART CANNOT BE INVESTIGATED ANY FURTHER BY FAT DEPARTMENT. THE FAILURE ANALYSIS AND TESTING DEPARTMENT VERIFIED THE BROKEN FIBER OPTIC CONNECTOR. RETAINING THE PART IN THE FAT DEPT. PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAS A DAMAGED FIBER OPTIC CONNECTOR. THE UNIT WAS NOT IN USE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760515 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown