BEUDAMED
    FDA Adverse Event Death Summary report: N

    KOALA

    MDR report key: 2944237 · Received January 31, 2013

    Report

    Report Number
    2944237
    Event Type
    Death
    Date Received
    January 31, 2013
    Date of Event
    September 27, 2012
    Report Date
    January 29, 2013
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Product Code
    HFN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A RETROSPECTIVE REVIEW OF UNEXPECTED FETAL OUTCOMES IN (B)(6) 2013 IT IS BELIEVED THAT THE FOLLOWING IUPC DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THIS FETAL DEMISE. PRIOR TO DELIVERY OF A LABORING PATIENT ON (B)(6) 2012, AN IUPC DEVICE WAS INSERTED INTO MOTHER. THIS IUPC DEVICE DID NOT APPEAR TO BE FUNCTIONING APPROPRIATELY AND A 2ND IUPC WAS DEPLOYED. FOLLOWING THIS DEPLOYMENT FETAL HEART TONES DIMINISHED AND AN EMERGENT C-SECTION WAS PERFORMED. INFANT DEMISE SHORTLY AFTER DELIVERY. AT THE TIME OF THIS EVENT IT WAS THOUGHT THAT THE DEATH WAS RELATED TO AN ATYPICAL ABRUPTION. SUBSEQUENT INVESTIGATION INTO THIS EVENT ALONG WITH PATHOLOGY REPORTS AND LABORATORY VALUES INDICATE THAT THE IUPC DEVICE MAY HAVE CAUSED A KNICK IN A PLACENTAL BLOOD VESSEL, WHICH MAY HAVE CONTRIBUTED TO A SIGNIFICANT LOSS OF FETAL BLOOD INCOMPATIBLE WITH LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43423 KOALA INTRAUTERINE PRESSURE CATHETER HFN CLINICAL INNOVATIONS, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Death