BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBEROPTIX ULTRA 8 IAB: 8FR 40CC

    MDR report key: 14719111 · Received June 16, 2022

    Report

    Report Number
    3010532612-2022-00228
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 27, 2022
    Report Date
    May 27, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    00801902007247
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THERE IS AN INVESTIGATION ONGOING INTO THIS REPORTED COMPLAINT. A SUPPLEMENT FOLLOW-UP MDR REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT OF IAB BLOOD IN HELIUM PATHWAY IS NOT ABLE TO BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE CUSTOMER PROVIDED A PICTURE WHICH WAS REVIEWED; IN THE PHOTO, IT SHOWS THE IABP DISPLAY SCREEN WITH BPW AND TRANSDUCER WAVEFORM. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED AFTER THE REVIEW OF THE PICTURE. MDR 3010532612-2022-00229 SUBMITTED FOR DETAILS OF ASSOCIATED COMPLAINTS WITH THE SAME PATIENT. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THE REPORTED COMPLAINT WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CLINICAL SUPPORT SPECIALIST (CSS) THAT THERE WAS BLOOD IN THE GAS TUBING. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED WITH A SECOND CATHETER. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY, OR DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CLINICAL SUPPORT SPECIALIST (CSS) THAT THERE WAS BLOOD IN THE GAS TUBING. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED WITH A SECOND CATHETER. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY, OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208080 FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN000254 18F20F0031 00801902007247

    Patients

    Seq Age Sex Outcome Treatment
    1 Male