BEUDAMED
    FDA Adverse Event Death Summary report: N

    CATHETER IUPC EXTERNAL KOALA

    MDR report key: 2111695 · Received May 27, 2011

    Report

    Report Number
    2111695
    Event Type
    Death
    Date Received
    May 27, 2011
    Date of Event
    April 9, 2011
    Report Date
    May 20, 2011
    Manufacturer
    CLINICAL INNOVATIONS LLC
    Product Code
    HFN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADMITTED TO OB UNIT ON (B)(6) 2011 AT 38.5 WEEKS GESTATION FOR SCHEDULED INDUCTION DUE TO LARGE FIBROIDS. PT WITH 5'6", AND (B)(6) ADMITTED TO OB UNIT AT 0813. PITOCIN STARTED AT 0920. HAD SROM (CLEAR) AT 1114. EPIDURAL STARTED AT 1400. AT 1516, SVE BY OB PHYSICIAN NOTED 4-5/70%/-2. AT 1517, IUPC AND FETAL SCALP ELECTRODE INSERTED BY OB PHYSICIAN. BLOOD NOTED IN IUPC AND REMOVED BY OB PHYSICIAN. NEW IUPC INSERTED. AT 1519, FETAL BRADYCARDIA NOTED. DEVELOPED PROLONGED DECELERATIONS. HAD EMERGENT C-SECTION DELIVERY AT 1534. DURING C-SECTION NOTED LARGE LOWER UTERINE SEGMENT FIBROIDS, VELAMENTOUS INSERTION OF UMBILICAL CORD, SMALL AMOUNT OF DARK BLOOD WITHIN UTERUS, NO LARGE AMOUNT, NO BRIGHT RED BLEEDING; SMALL FOR GESTATIONAL AGE-APPEARING PLACENTA. INFANT REQUIRED RESUSCITATION AS HAD NO PULSE. WAS TRANSPORTED TO NICU AT 1810. REQUIRED RESUSCITATION ATTEMPT AGAIN AND WAS PRONOUNCED DEAD AT 2245. INFANT AUTOPSY INDICATES UMBILICAL CORD LACERATION THAT LED TO HYPOVOLEMIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER IUPC EXTERNAL KOALA IUPC HFN CLINICAL INNOVATIONS LLC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death EPIDURAL CATHETER INSTILLING PAIN MEDICATION| FETAL SCALP ELECTRODE| PITOCIN DRIP