BEUDAMED
    FDA Adverse Event Death Summary report: N

    KOALA INTRAUTERINE PRESSURE CATHETER

    MDR report key: 724537 · Received June 8, 2006

    Report

    Report Number
    1722684-2006-00004
    Event Type
    Death
    Date Received
    June 8, 2006
    Report Date
    June 7, 2006
    Manufacturer
    CLINICAL INNOVATIONS
    Product Code
    HGS
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSP DID NOT REPORT THIS EVENT TO US; HOWEVER, OUR AUTHORIZED DEALER DID LEARN OF THE EVENT AND IMMEDIATELY CONTACTED OUR OFFICE. OUR MEDICAL DIRECTOR CONTACTED THE HOSPITAL'S CLINICAL NURSE SPECIALIST TO GET MORE INFORMATION. CLINICAL NURSE SPECIALIST INFORMED MEDICAL DIRECTOR THAT SHE DIDN'T THINK THE KOALA CATHETER WAS AT FAULT, BUT BELIEVED THE RESIDENT WHO PLACED THE CATHETER DID NOT KNOW HOW TO USE THE DEVICE PROPERLY. THOUGH WE CANNOT TELL IF THE KOALA CATHETER ACTUALLY CAUSED THE PLACENTAL ABRUPTION, MISUSE OF THE DEVICE CAN CAUSE DIFFICULTIES. ONE OF THE MAJOR BENEFITS OF THE KOALA'S CLEAR LUMEN IS THAT UPON INITIAL INSERTION, THE CLINICIAN CAN QUICKLY DETERMINE IF THE CATHETER HAS BEEN PLACED OUTSIDE OF THE AMNIOTIC SPACE. ACCORDING TO OUR INSTRUCTIONS FOR USE AND PACKAGING, THE CLINICIAN IS TO ONLY INSERT THE CATHETER ABOUT 8 CM, TO THE LINE THAT SAYS "PAUSE FOR FLASHBACK," AND WAIT TO SEE IF AMNIOTIC FLUID OR BLOOD RETURNS DOWN THE CATHETER. IF BLOOD RETURNS, THE CATHETER IS NOT TO BE INSERTED ANY FURTHER, BUT RATHER WITHDRAWN AND REINSERTED INTO ANOTHER QUADRANT WHERE A RETURN OF AMNIOTIC FLUID CAN BE OBTAINED. ONCE AMNIOTIC FLUID IS SEEN, THE CATHETER CAN BE INSERTED COMPLETELY. ACCORDING TO THE CLINICAL NURSE SPECIALIST, THIS MOST BASIC CAUTION WAS NOT TAKEN. ALSO, OUR INSTRUCTIONS FOR USE CLEARLY INDICATE THAT A USER IS NEVER TO INFUSE FLUID THROUGH A CATHETER THAT IS KNOWN, OR EVEN SUSPECTED, TO BE PLACED OUTSIDE OF THE AMNIOTIC SPACE. FROM SPEAKING WITH THE CLINICAL NURSE SPECIALIST , THE RNS KNEW OF THE FEATURES AND BENEFITS OF THE KOALA DEVICE, BUT THE RESIDENT WHO PLACED IT DID NOT. WE HAVE OFFERED FOLLOW UP TRAINING AND ARE SENDING ADDITIONAL TRAINING MATERIALS TO THE HOSPITAL TO HELP AVOID A SIMILAR PROBLEM IN THE FUTURE.

    Description of Event or Problem · 1

    A FIRST-TIME MOM WAS IN THE L&D FOR INDUCTION. A KOALA CATHETER WAS PLACED BY A FIRST-YEAR RESIDENT. BRIGHT-RED BLOOD WAS SEEN IN THE LUMEN OF THE CATHETER; HOWEVER, THE CATHETER WAS ADVANCED TO THE 45 CM MARK WITHOUT DELAY AND LEFT IN PLACE. FETAL HEART TONES DROPPED TO THE LOW 100'S -- THEY PREVIOUSLY HAD BEEN REASSURING. A BOLUS OF FLUID (UNDOCUMENTED AMOUNT) WAS THEN ADMINISTERED THROUGH THE CATHETER IN AN ATTEMPT TO ALLEVIATE SUSPECTED CORD COMPRESSION. THE PT WAS ROLLED ON HER SIDE AND A LARGE AMOUNT OF BLOOD WAS VISUALIZED IN THE BED. THE CATHETER WAS REMOVED AND THE FETAL HEART DROPPED TO THE 90'S. A CESAREAN SECTION WAS PERFORMED APPROXIMATELY 8 MINUTES AFTER THE CATHETER WAS PLACED. EVIDENCE FOUND AT THE TIME OF THE SURGERY SHOWED A FRESH ABRUPTION. THEY WERE NOT ABLE TO RESUSCITATE THE INFANT AND THE MOTHER REQUIRED 2 UNITS OF BLOOD. THE PLACENTA WAS SENT TO PATHOLOGY AND THEY DID NOT REPORT A PERFORATION OR VASA PREVIA, BUT A FRESH ABRUPTION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOALA INTRAUTERINE PRESSURE CATHETER INTRAUTERINE PRESSURE CATHETER HGS CLINICAL INNOVATIONS KOALA IUPC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R