BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 7.5FR. 40CC IAB

    MDR report key: 7290536 · Received February 22, 2018

    Report

    Report Number
    2248146-2018-00120
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    February 1, 2018
    Report Date
    March 30, 2018
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DSP
    PMA / PMN Number
    K112327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    STAFF FOUND CONDENSATION IN THE TUBING, NO ALARM AT THAT POINT, 30 MINUTES LATER BLOOD NOTICED IN TUBING, THERE WAS AN ALARM, BUT THE CUSTOMER DOES KNOW WHICH ONE. INDICATION FOR USE HEART FAILURE. DATE OF BIRTH (B)(6) AND WEIGHT (B)(6). LOT/SERIAL NUMBER: (B)(4). CATALOG NO. FROM 0684-00-0575 TO 0684-00-0567. SENSATION PLUS 8FR. 50CC IAB TO SENSATION PLUS 7.5FR. 40CC IAB DEVICE EVALUATION: THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE INTERIOR AND EXTERIOR OF THE CATHETER. THE SENSOR CABLE WAS CUT INTO 2 PIECES AND THE EXTRACORPOREAL TUBING WAS NOT RETURNED. A VISUAL EXAMINATION OF THE PRODUCT DETECTED THE INNER LUMEN WITHIN THE MEMBRANE WAS COMPLETELY SEPARATED WITHIN A KINK APPROXIMATELY 24.6CM FROM IAB TIP. THE OPTICAL FIBER WAS FOUND TO BE BROKEN APPROXIMATELY 24.9CM FROM IAB TIP. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER AND Y-FITTING WAS PERFORMED AND NO OTHER LEAKS WERE DETECTED. ONE KINK WAS FOUND ON THE CATHETER TUBING APPROXIMATELY 77.7CM FROM THE IAB TIP. THE EVALUATION CONFIRMS THE REPORTED LEAK, BLOOD IN TUBING, ALARM, UNKNOWN PROBLEM. THE BREAK FOUND IN THE INNER LUMEN APPEARS TO HAVE BEEN THE RESULT OF A SEVERE KINK, WHICH EVENTUALLY FAILED AND ALLOWED BLOOD TO LEAK INTO THE MEMBRANE AND CATHETER TUBING CAUSING THE REPORTED LEAK, BLOOD IN TUBING, ALARM, UNKNOWN PROBLEM. IT IS DIFFICULT TO DETERMINE WHEN THE BREAK OCCURRED BUT IT IS POSSIBLY A RESULT OF PATIENT MOVEMENT DURING THE PROCEDURE. THE OPTICAL FIBER WAS FOUND TO BE BROKEN. WE ARE UNABLE TO DETERMINE WHEN THIS MAY HAVE OCCURRED. A DEVICE AND LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NON-CONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY BLOOD WAS NOTED IN THE IAB TUBING AND AN UNSPECIFIED ALARM WAS GENERATED. THE INSERTION WAS SUBCLAVIAN. THE IAB WAS REPLACED WITH ANOTHER ONE. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY BLOOD WAS NOTED IN THE IAB TUBING AND AN UNSPECIFIED ALARM WAS GENERATED. STAFF FOUND CONDENSATION IN THE TUBING, NO ALARM AT THAT POINT, 30 MINUTES LATER BLOOD NOTICED IN TUBING, THERE WAS AN ALARM, BUT THE CUSTOMER DOES KNOW WHICH ONE. THE INSERTION WAS SUBCLAVIAN. THE IAB WAS REPLACED WITH ANOTHER ONE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE INDICATION FOR USE WAS HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131561 SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE FAIRFIELD 3000058287

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR