BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBB COMPLETE TAMPONADE SYSTEM

    MDR report key: 4376818 · Received December 23, 2014

    Report

    Report Number
    1722684-2014-00001
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    November 26, 2014
    Report Date
    December 23, 2014
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    OQY
    PMA / PMN Number
    K091958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY REPORTED. PT HAD STABILIZED AT TIME MALFUNCTION WAS NOTED. DEVICE DISCARDED, NO EVAL COULD BE PERFORMED.

    Description of Event or Problem · 1

    (B)(6) WAS CALLED IN TO ASSIST A LOCAL PRACTITIONER WITH A PT SUFFERING FROM A POST-PARTUM HEMORRHAGE AT 12:30AM ON WEDNESDAY (B)(6). THE PT WAS S/P CESAREAN SECTION AND HAD BLEED NEARLY 3 LITERS BY THE TIME (B)(6) ENTERED THE SCENE. HER CERVIX WAS APPROXIMATELY 2CM DILATED. (B)(6) PERFORMED A D AND C TO REMOVE ANY RETAINED PLACENTAL PRODUCTS AND THEN PLACED THE EBB CATHETER (V 2) WITHOUT DIFFICULTY. HE IMMEDIATELY FILLED THE UTERINE BALLOON TO 1200 CC AND THE VAGINAL BALLOON TO 300 CC. WHEN ASKED WHY HE FILLED THE UTERINE BALLOON BEYOND IT'S RECOMMENDED VOLUME, HE STATED THAT SHE WAS SUFFERING FROM SEVERE GLOBAL ATONY AND REQUIRED THE GREATER AMOUNT TO ACCOMMODATE HER UTERUS. THE BLEEDING STOPPED SHORTLY AFTER INSERTION OF THE EBB CATHETER AND THE PT WAS PLACED IN THE ICU FOR CONTINUOUS MONITORING. AT 6:30AM ON (B)(6), (B)(6) PLACED A CALL TO THE ICU TO CHECK ON THE STATUS OF THE PT AND THEY REPORTED THAT SHE WAS STABLE AND HER BLEEDING HAD NOT CONTINUED. THE UTERUS HAD CONTRACTED TO THE LEVEL OF THE UMBILICUS AT THAT POINT. AT APPROXIMATELY 3:00PM ON (B)(6), (B)(6) RECEIVED A CALL FROM THE PRACTITIONER WHO REPORTED THAT WHEN THEY WENT TO REMOVE THE EBB DEVICE, THEY FOUND WHAT APPEARED TO BE WATER IN THE BED AND ON THE FLOOR AROUND THE PT. WHEN THEY REMOVED THE DEVICE, IT APPEARED THE UTERINE BALLOON HAD RUPTURED/LEAKED AND WAS NO LONGER INTACT (DID NOT REQUIRE ANY DRAINAGE). THE PT REMAINED STABLE AND DID NOT HAVE ANY RECURRENCE OF HER BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847280 EBB COMPLETE TAMPONADE SYSTEM EBB COMPLETE TAMPONADE SYSTEM OQY CLINICAL INNOVATIONS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK