BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANS-RAY PLUS 7.5 FR. 35CC IAB

    MDR report key: 13663742 · Received March 3, 2022

    Report

    Report Number
    2248146-2022-00181
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    February 3, 2022
    Report Date
    April 14, 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 BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. COMPLAINT RECORD ID#: (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE EXTERIOR OF THE CATHETER. TWO KINKS WERE FOUND ON THE CATHETER TUBING AND INNER LUMEN NEAR THE Y-FITTING APPROXIMATELY 71.6CM AND 73.7CM FROM THE IAB TIP. A SENSOR OUTPUT TEST WAS PERFORMED AND A PRESSURE READING COULD NOT BE OBTAINED. THE TECHNICIAN THEN USED AN OPTICAL LIGHT TO DETECT ANY BREAKS IN THE SENSOR'S OPTICAL FIBER AND A BREAK WAS OBSERVED WITHIN THE Y-FITTING. THE OPTICAL FIBER WAS FOUND TO BE BROKEN, CONFIRMING THE REPORTED PROBLEM. 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 MAR-2020 TO FEB-2022 WAS REVIEWED. COMMUNICATION/INTERVIEWS: (4111/213) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. REFERENCE COMPLAINT #(B)(4).

    Additional Manufacturer Narrative · 0

    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 · 0

    N/A.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN CONNECTING THE INTRA-AORTIC BALLOON (IAB) TO THE CONSOLE, THE BLOOD PRESSURE WAVEFORM BECAME ABNORMAL AND DISPLAYED AS ZERO. THE CONSOLE WAS REPLACED WITH ANOTHER AND THE PRESSURE WAVEFORM WAS DISPLAYED AGAIN. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932234 TRANS-RAY PLUS 7.5 FR. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 3000128507

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CARDIOSAVE AND CS100.