BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBEROPTIX ULTRA 8 IAB: 8FR 40CC

    MDR report key: 8283240 · Received January 28, 2019

    Report

    Report Number
    3010532612-2019-00019
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    January 6, 2019
    Report Date
    January 7, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    UDI-DI
    00801902007247
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). TELEFLEX RECEIVED THE DEVICE FOR INVESTIGATION. THE REPORTED COMPLAINT OF FOS WOULD NOT ZERO IS CONFIRMED. THE FOS WAS RETURNED WITH A RECESSED CONNECTOR AND THE FIBER WAS BROKEN; THEREFORE, A LIGHT PATH COULD NOT BE ESTABLISHED BETWEEN THE SENSOR AND THE PUMP. THE ROOT CAUSE OF THE RECESSED FOS AND THE BROKEN FIBER IS UNDETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. TELEFLEX ASSESSED THE RISK FOR THE REPORTED COMPLAINT. THERE ARE NO NEW OR REVISED RISKS. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS. NO FURTHER ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON PREPARING THE INTRA-AORTIC BALLOON (IAB) BEFORE INSERTION, THE FIBER OPTIC (FO) WAS NOT RECOGNIZED BY THE PUMP. THE STAFF REMOVED AND REINSERTED THE FO A FEW TIMES WITHOUT SUCCESS. THE PUMP WAS SWAPPED OUT, AND THE PUMP DID NOT READ THE FO SENSOR. AS A RESULT, THE IAB WAS REPLACED WITH ANOTHER IAB. THERE WAS NO REPORT OF PATIENT COMPLICATION OR SERIOUS INJURY AND DEATH.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON PREPARING THE INTRA-AORTIC BALLOON (IAB) BEFORE INSERTION, THE FIBER OPTIC (FO) WAS NOT RECOGNIZED BY THE PUMP. THE STAFF REMOVED AND REINSERTED THE FO A FEW TIMES WITHOUT SUCCESS. THE PUMP WAS SWAPPED OUT, AND THE PUMP DID NOT READ THE FO SENSOR. AS A RESULT, THE IAB WAS REPLACED WITH ANOTHER IAB. THERE WAS NO REPORT OF PATIENT COMPLICATION OR SERIOUS INJURY AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73763 FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL INC. 18F17M0028 00801902007247

    Patients

    Seq Age Sex Outcome Treatment
    1