BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 18345899 · Received December 18, 2023

    Report

    Report Number
    2249723-2023-05326
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    December 6, 2023
    Report Date
    September 3, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, D9, G3, G6, H2, H3, H4, H6, H10. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND CONFIRMED FAULT CODE #53. AFTER INSPECTION OF THE EXECUTIVE PROCESSOR BOARD, THE FSE FOUND TRACES OF CORROSION, WATERMARKS, AND CRYSTALLIZATION OF SALINE ON THE EXECUTIVE PROCESSOR BOARD. IT WAS ALSO NOTICE BY THE FSE THAT THE IV POLE WAS NOT IN ITS CORRECT POSITION AS IT WAS FACING INWARD HANGING OVER THE IABP. THE IV POLE WAS CRACKED, AS IT WAS FORCED INTO THE POSITION IT WAS FOUND IN. A BROKEN FIBER OPTIC SENSOR EXTENSION CABLE WAS FOUND AS WELL. THE FSE REPLACED PARTS AND AND PERFORMED A PM, FULL CALIBRATION, AND TESTED THE UNIT. THE PRODUCT PASSED ALL FUNCTIONAL/SAFETY TESTING AND WAS RETURNED TO THE CUSTOMER. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER 0012-00-1562 REV. H SERIAL NUMBER (B)(6) RECEIVED WITH REPORTED PHYSICAL DAMAGE PART NUMBER 0670-00-0770 REV. REV. I SERIAL NUMBER (B)(6) RECEIVED WITH A REPORTED SALINE SPILL/CORROSION. PART NUMBER 0436-00-0274 - RECEIVED WITH REPORTED PHYSICAL DAMAGE. PERFORMED A VISUAL INSPECTION AND FOUND PART NUMBER 0012-00-1562 AND PART NUMBER 0436-00-0274 TO HAVE PHYSICAL DAMAGE AS REPORTED. PLEASE SEE ATTACHMENTS. PERFORMED A VISUAL INSPECTION AND FOUND PART NUMBER 0670-00-0770 AND OBSERVED WHITE RESIDUE ON THE PART WHICH IS CONSISTENT WITH SALINE. CAPA (B)(4) HAS BEEN INITIATED TO ADDRESS THIS ISSUE. FAT WAS ABLE TO VERIFY THE REPORTED ISSUES ON THESE PARTS BUT NO ROOT CAUSE ABLE TO BE DEFINED. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS A FAULT CODE #53.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718564 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