BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 7.5FR. 40CC IAB

    MDR report key: 12934508 · Received December 6, 2021

    Report

    Report Number
    2248146-2021-00822
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 11, 2021
    Report Date
    February 11, 2022
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    PMA / PMN Number
    K122628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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). DEVICE NOT RETURNED.

    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. THE INNER LUMEN WAS FOUND OCCLUDED WITH DRIED BLOOD. THE OCCLUSION WAS ABLE TO BE CLEARED. A SENSOR OUTPUT TEST WAS PERFORMED AND THE SENSOR WAS FOUND TO BE WITHIN SPECIFICATION. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND NO LEAKS WERE DETECTED. THE REPORTED EVENT CANNOT BE CONFIRMED BY THE EVALUATION. 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 DEC-2019 TO NOV-2021 WAS REVIEWED. COMMUNICATION/INTERVIEWS: (4111/213) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. REFERENCE COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: PATIENT INFORMATION: 62 YEARS, DATE OF BIRTH: (B)(6) 1959, SEX: FEMALE, WEIGHT: 54 KG EVENT SITE EMAIL: (B)(6). REFERENCE COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, A FIBER OPTIC SENSOR FAILURE OCCURRED AND THERE WERE NO READINGS DISPLAYED ON THE CONSOLE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833199 SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 3000150831

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female CS300 / SI01659-G7