BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19886189 · Received August 1, 2024

    Report

    Report Number
    2249723-2024-03093
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 11, 2024
    Report Date
    October 23, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE GETINGE FIELD SERVICE ENGINEER (FSE) THAT DISCOVERED THE ISSUE REPLACED IV POLE LOCK AND BUSHING, THIS CORRECTED THE ISSUE. DEVICE PASSED ALL FUNCTIONAL AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. NO PATIENT INVOLVED AND NO HARM REPORTED. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE FOLLOWING INVESTIGATION WAS PERFORMED BY THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT). THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER 0358-00-0073 IV POLE BUSHING SERIAL NUMBER N/A PART NUMBER 0105-00-0129 IV POLE LOCK SERIAL NUMBER N/A. THE FAT DEPT. ASSEMBLED THE IV POLE BUSHING INTO THE IV POLE LOCK. THEN PROCEEDED TO INSTALL THE IV POLE INTO THE LOCK AND BUSHING. THE IV POLE WOULD NOT LOCK INTO THE BUSHING AND LOCK. THE FAT DEPT. WAS ABLE TO REPLICATE THE FAILURE OF THE IV POLE NOT STAYING UP. THE PARTS FAILED TESTING. RETAINING THE PARTS IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV.AR. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE BY GETINGE FIELD SERVICE ENGINEER, THE IV POLE OF THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS NOT STAYING UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985145 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