BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 7.5FR. 40CC IAB

    MDR report key: 13159091 · Received January 4, 2022

    Report

    Report Number
    2248146-2022-00007
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 14, 2021
    Report Date
    February 2, 2022
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    UDI-DI
    10607567108605
    PMA / PMN Number
    K122628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTER NAME: (B)(6). 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

    BRAND NAME CORRECTED FROM "SENSATION PLUS 8FR. 50CC IAB" TO "SENSATION PLUS 7.5FR. 40CC IAB". CATALOG # CORRECTED FROM "0684-00-0575" TO "0684-00-0567". UNIQUE IDENTIFIED (UDI) # CORRECTED FROM "10607567108605" TO "(B)(4)". SERIAL # UPDATED TO (B)(6). LOT # UPDATED TO 3000139741. MANUFACTURE DATE UPDATED 01/06/2021. EXPIRATION DATE UPDATED 01/06/2021. PMA/510(K)# UPDATED TO K122628. THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE EXTERIOR OF THE CATHETER. A NON-MAQUET SHEATH WAS RETURNED SEPARATE FROM THE IAB. 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 NO BREAKS WERE OBSERVED ALONG THE LENGTH OF THE OPTICAL FIBER. THE EVALUATION CONFIRMED THE REPORTED SENSOR FAILURE. HOWEVER, WE ARE UNABLE TO DETERMINE HOW THIS FAILURE MAY HAVE OCCURRED AND HAS BEEN ESCALATED TO RESPECTIVE SUPPLIER TO DETERMINE A ROOT CAUSE. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, AN AUTO-FILL FAILURE OCCURRED AND PUMPING STOPPED. THE IAB WAS REMOVED AND REPLACED WITH A NEW ONE. AFTER INSERTION OF THE SECOND IAB, THE CONSOLE GENERATED A FIBER OPTIC SENSOR FAILURE MESSAGE. THE CUSTOMER DISCONNECTED AND RECONNECTED THE FO CABLE WITH THE SAME RESULT. FLUERO SHOWS CORRECT PLACEMENT OF THE IAB AND THE INSERTION SITE WAS NOTED TO BE FEMORAL. THEY WERE ADVISED TO SWITCH TO THE CENTRAL LUMEN TO TRANSDUCE PRESSURE. THEY HAVE NOT CONNECTED A FLUSH LINE, BUT THE CUSTOMER STATED THEY WILL DO THIS AND ATTEMPT TO PROVIDE THE ARTERIAL LINE THIS WAY. THEY UNDERSTAND HOW TO DO THIS AND STATED THEY NO LONGER NEEDED ASSISTANCE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE FIRST IAB USED IN THIS EVENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE SECOND IAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494733 SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 0684-00-0576-01 3000139741 10607567108605

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male