BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 14574408 · Received June 2, 2022

    Report

    Report Number
    2249723-2022-01292
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 11, 2022
    Report Date
    September 5, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT REPORTED TO BE 5'10". A GETINGE FIELD SERVICE ENGINEER INSPECTED THE UNIT AND WAS ABLE TO CONFIRM THE ISSUE WITH THE FIBER OPTIC MODULE BY TESTING IN SERVICE MODE USING A FIBER OPTIC TESTER. FSE REPLACED THE FIBER OPTIC MODULE. THE UNIT PASSED FIBER OPTIC MODULE TESTS. FUNCTIONAL TESTING AND SAFETY CHECKS WERE PERFORMED TO FACTORY SPECIFICATIONS. THE UNIT ALSO PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE FIBER OPTIC MODULE PART NUMBER 0997-00-1169 WAS PERFORMED BY TECHNICIAN OF THE MAQUET NATIONAL REPAIR CENTER(NRC). THE FIBER OPTIC MODULE WAS OBSERVED PER THE CARDIOSAVE SERVICE MANUAL WITH NO VISUAL DAMAGE. THE NATIONAL REPAIR CENTER INSTALLED THE FIBER OPTIC MODULE INTO THE CARDIOSAVE TEST FIXTURE AND TESTED THE FIBER OPTIC MODULE TO FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL. FIBER OPTIC MODULE WAS NON FUNCTIONAL DURING TESTING.. THE FIBER OPTIC MODULE BOARDS P/N 0670-00-1160 AND 0992-00-1017 WILL BE SENT TO THE RESPECTED SUPPLIERS FOR FAILURE ANALYSIS PER PROCEDURE. THE FAILURE AND ANALYSIS DEPT.(FAT) RECEIVED PART NUMBER: 0670-00-1160 FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING: PERFORM VISUAL CHECK. RESULT: NO ABNORMALITIES FOUND. BOARD WAS RE-TESTED AT FCT . RESULT: PASSED. RESULTS AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF. THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CARDIOSAVE INTRAAORTIC BALLOON PUMP (IABP) UNIT WAS NOT WORKING PROPERLY WHILE IN USE ON A PATIENT. COMPLICATION OCCURRED MID-PROCEDURE AFTER IAB WAS INSERTED. FIBEROPTIC CONNECTION CHECKED, BALLOON PLACEMENT CONFIRMED, PUMP WAS RESTARTED. NO CORRECT FIBEROPTIC WAVEFORM WAS DETECTED, ONLY ARTIFACT. PATIENT WAS INVOLVED, AND THE ISSUE WAS RESOLVED BY USING THE BACKUP IABP. NO INJURY, DEATH, OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159102 CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 N/A 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male BALLOON- SENSATION 7FR 40CC