BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 8FR. 50CC IAB

    MDR report key: 8790642 · Received July 15, 2019

    Report

    Report Number
    2248146-2019-00598
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    June 27, 2019
    Report Date
    September 5, 2019
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    PMA / PMN Number
    K112327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SECTION A - PATIENT INFORMATION PATIENT ID FROM: [BLANK] TO: JMG SEX FROM: UNKNOWN TO: MALE DATE OF BIRTH FROM: [BLANK] TO: (B)(6) 1947 AGE AT TIME OF EVENT FROM: [BLANK] TO: 72 WEIGHT FROM: [BLANK] TO: 81 THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE EXTERIOR OF THE CATHETER. ONE KINK WAS LOCATED ON THE CATHETER TUBING APPROXIMATELY 58.9CM FROM THE IAB TIP. THE OPTICAL FIBER WAS FOUND TO BE BROKEN NEAR THE KINKED LOCATION APPROXIMATELY 58.7CM FROM THE IAB TIP. THE OPTICAL FIBER WAS FOUND TO BE BROKEN, CONFIRMING THE REPORTED ALARM. A DEVICE AND 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)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE CONSOLE GENERATED AN OPTICAL SENSOR FAILURE ALARM. THERE WAS NO LOSS OF PRESSURE INDICES ON THE CONSOLE. THE CUSTOMER TRANSDUCED THE FLUID LUMEN TO OBTAIN ADEQUATE ARTERIAL WAVEFORM. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE CONSOLE GENERATED AN OPTICAL SENSOR FAILURE ALARM. THERE WAS NO LOSS OF PRESSURE INDICES ON THE CONSOLE. THE CUSTOMER TRANSDUCED THE FLUID LUMEN TO OBTAIN ADEQUATE ARTERIAL WAVEFORM. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584395 SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 3000092766

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR