BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES

    MDR report key: 19212072 · Received April 30, 2024

    Report

    Report Number
    2248146-2024-00268
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Report Date
    December 20, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108063
    PMA / PMN Number
    K122628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELD(S): HEALTH PROFESSIONAL? OCCUPATION: MS, ARNP, CNOR, FNP-BC, RN SURGICAL SPECIALIST ADDITIONAL INFORMATION RECEIVED 09MAY2024. UPDATED FIELD(S) - BRAND NAME SERIAL # / LOT # UDI NUMBER CATALOG # MANUFACTURE DATE/ EXP. DATE.

    Additional Manufacturer Narrative · 0

    OCCUPATION: PEACEHEALTH ADMINISTRATOR THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER, BUT IS PENDING INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WITH OUR FINDINGS WILL BE SUBMITTED. 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. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND NO LEAKS WERE DETECTED. THE IAB WAS PLACED ON THE CARDIOSAVE PUMP AND THE IAB FULLY INFLATED. NO ALARM SOUNDED FROM THE PUMP. THE REPORTED EVENT CANNOT BE CONFIRMED BY THE EVALUATION. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. REFERENCE COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID. COMPLAINT RECORD ID (B)(4).

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE BALLOON WOULD NOT OPEN. 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
    154056 SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0568-01 3000319345 10607567108063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.