BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOALA INTRAUTERINE PRESSURE CATHETER

    MDR report key: 19230704 · Received May 2, 2024

    Report

    Report Number
    1722684-2024-00008
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    March 9, 2024
    Report Date
    May 1, 2024
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HFN
    UDI-DI
    00814247020178
    PMA / PMN Number
    K974389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS NOT CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOS WERE PROVIDED. ADDITIONALLY, REQUESTED FOLLOW-UP INFORMATION FROM THE INITIAL REPORTER WAS NOT PROVIDED. INVESTIGATION DESCRIPTION A DHR REVIEW WAS PERFORMED AND NO DEVIATIONS OR NCRS WERE FOUND TO BE INITIATED. THE RISK PROFILE BELOW WAS DETERMINED BY THE CLINICAL TEAM. ITEM : USE DEVICE FOR AMNIOINFUSION. POTENTIAL FAILURE MODES: USER FAILS TO RECOGNIZE THAT THERE IS NO FLUID RETURN DURING AMNIOINFUSION POTENTIAL EFFECTS: INCREASED INTRAUTERINE VOLUME COULD INCREASE RISK OF UTERINE RUPTURE HARM: INJURY AND/OR DEATH TO FETUS AND/OR PATIENT SEVERITY: 4 ROOT CAUSE ANALYSIS A ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. USER ERROR AND DEVICE MALFUNCTION CANNOT BE RULED OUT AS POTENTIAL ROOT CAUSES.

    Description of Event or Problem · 0

    IN THE CUSTOMERS WORDS: "UTERINE RUPTURE AFTER USING IUPC FOR AMNIOINFUSION. IUPC PLACED AT 0254. AMNIOINFUSION STARTED AT 0905 300 ML BOLUS AT RATE OF 999ML/HR THEN 50 ML/HR. WAS STARTED APPROXIMATELY 90 MINUTES PRIOR TO IDENTIFICATION OF UTERINE RUPTURE. NO FLUID RETURNED FROM AMNIOINFUSION, ABDOMEN PALPATED SOFT BETWEEN CONTRACTIONS. URGENT C/S DUE TO CONCERN FOR UTERINE RUPTURE, EXHIBITED CHANGE IN SVE AND LOSS OF ABILITY TO FIND FHT WITH EXTERNAL AND INTERNAL MONITORS. SURGEON NOTED PLACENTAL FRAGMENTS AND FETAL HEAD PALPABLE EXTRAUTERINE CONSISTENT WITH UTERINE RUPTURE. THERAPY DURATION: 1.5 HOUR. UTERINE ACTIVITY, MEASUREMENT OF MVUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411115 KOALA INTRAUTERINE PRESSURE CATHETER TRANSDUCER, PRESSURE, INTRAUTERINE HFN CLINICAL INNOVATIONS, LLC IPC-5000E 231411 00814247020178

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown