BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANS-RAY PLUS 7.5 FR. 40CC IAB

    MDR report key: 12370908 · Received August 26, 2021

    Report

    Report Number
    2248146-2021-00552
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    August 5, 2021
    Report Date
    April 28, 2022
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. ANALYSIS OF PRODUCTION (3331/213) - THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT/SERIAL NUMBER. BASED ON THE REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE MANUFACTURING PROCESS AND THE REPORTED FAILURE. HISTORICAL DATA ANALYSIS (4109/213) - THE REVIEW OF THE HISTORICAL DATA WAS PERFORMED. TREND ANALYSIS (4110/213) - THE OVERALL COMPLAINT TREND DATA FOR THE PERIOD AUG-2019 THROUGH JUL-2021 WAS REVIEWED. COMMUNICATION/INTERVIEWS: (4111/213) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. REFERENCE COMPLAINT #(B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. REFERENCE COMPLAINT#: (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE EXTERIOR OF THE CATHETER. THE OPTICAL FIBER WAS FOUND TO BE BROKEN WITHIN THE MEMBRANE APPROXIMATELY 5.1CM FROM IAB TIP. THE OPTICAL FIBER WAS FOUND TO BE BROKEN, CONFIRMING THE REPORTED PROBLEMS. WE ARE UNABLE TO DETERMINE WHEN THIS MAY HAVE OCCURRED. A NON-CONFORMING MATERIAL REPORT REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. ANALYSIS OF PRODUCTION (3331/213) - THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT/SERIAL NUMBER. BASED ON THE REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE MANUFACTURING PROCESS AND THE REPORTED FAILURE. HISTORICAL DATA ANALYSIS (4109/213) - THE REVIEW OF THE HISTORICAL DATA WAS PERFORMED. TREND ANALYSIS (4110/213) - THE OVERALL COMPLAINT TREND DATA FOR THE PERIOD AUG-2019 THROUGH JUL-2021 WAS REVIEWED. COMMUNICATION/INTERVIEWS: (4111/213) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. REFERENCE COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    EVENT SITE POSTAL CODE: (B)(6). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. COMPLAINT RECORD ID # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONCE THE INTRA-AORTIC BALLOON (IAB) HAD BEEN INSERTED AND CONNECTED TO THE CONSOLE, THE BLOOD PRESSURE WAVEFORM WAS NOT DISPLAYED AND THE CONSOLE GENERATED A FIBER OPTIC SENSOR FAILURE ALARM. A NEW IAB WAS PLACED AND THE BLOOD PRESSURE WAVEFORM WAS DISPLAYED WITHOUT ISSUE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268508 TRANS-RAY PLUS 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 3000125561

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CARDIOSAVE| CARDIOSAVE