BEUDAMED
    FDA Adverse Event Death Summary report: N

    NA

    MDR report key: 6270846 · Received January 23, 2017

    Report

    Report Number
    1218950-2017-00523
    Event Type
    Death
    Date Received
    January 23, 2017
    Date of Event
    October 7, 2016
    Report Date
    January 19, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGS
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT, AFTER THE PLACENTA LOCALIZATION, THE CLINICIAN INTRODUCED THE PRODUCT WITHOUT ANY RESISTANCE FOLLOWING THE PROCEDURE OF THE USER GUIDE. WITHIN A HALF OF A MINUTE OF INSERTION OF THE PRODUCT, THE BABY REPORTEDLY WENT INTO A BRADYCARDIA CONDITION. THE PATIENT WAS WITHIN 9 MINUTES AT THE O.R. ROOM FOR A CESAREAN WHERE THE BABY WAS BORN AFTER 15 MINUTES, BUT THE BABY HAD DIED. THERE REPORTEDLY WAS A LESION AT THE PLACENTA BECAUSE OF THE PRODUCT. PHILIPS CLINICAL EVALUATION OF THE INFORMATION MADE AVAILABLE TO PHILIPS BY THE HOSPITAL WAS PERFORMED. PHILIPS¿ CLINICAL OPINION IS THAT THE LESION WAS LIKELY LOCATED IN THE UMBILICAL VEIN (NOT PLACENTAL VEIN AS PREVIOUSLY REPORTED), BASED ON THE TIMING OF THE EVENTS (BRADYCARDIA WITHIN 30 SECONDS). IT IS POSSIBLE THAT THE LESION COULD HAVE BEEN CAUSED BY THE IUPC (INTRAUTERINE PRESSURE CATHETER) DEVICE, BUT THE POSSIBILITY THAT THE LESION WAS CAUSED BY OTHER MEANS COULD NOT BE RULED OUT. ACCORDING TO PHILIPS¿ SUPPLIER OF THIS PRODUCT, THE TWO CONDITIONS COULD POSSIBLY LEAD TO AN UMBILICAL VEIN LESION BY THE IUPC DEVICE ARE EITHER DEVICE-RELATED (HARD IUPC TIP) OR APPLICATION-RELATED (FAILURE TO FOLLOW IFU). THE AVAILABLE INFORMATION DOES NOT SUPPORT THAT EITHER OF THESE CONDITIONS WERE PRESENT DURING THIS INCIDENT. THEREFORE, IF THE IUPC DEVICE CAUSED THE LESION IN THE UMBILICAL VEIN, IT IS NOT KNOWN WHY OR HOW THIS OCCURRED. AS A RESULT, WE ARE CONSIDERING THIS TO BE A MALFUNCTION FOR REPORTING PURPOSES ONLY.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT, AFTER THE PLACENTA LOCALIZATION, THE CLINICIAN INTRODUCED THE PRODUCT WITHOUT ANY RESISTANCE FOLLOWING THE PROCEDURE OF THE USER GUIDE. WITHIN A HALF OF A MINUTE OF INSERTION OF THE PRODUCT, THE BABY REPORTEDLY WENT INTO A BRADYCARDIA CONDITION. THE PATIENT WAS WITHIN 9 MINUTES AT THE OPERATING ROOM FOR A CESAREAN WHERE THE BABY WAS BORN AFTER 15 MINUTES, BUT THE BABY HAD DIED. THERE REPORTEDLY WAS A LESION AT THE PLACENTA BECAUSE OF THE PRODUCT. PHILIPS CLINICAL EVALUATION OF THE INFORMATION MADE AVAILABLE BY THE HOSPITAL WAS PERFORMED. PHILIPS¿ CLINICAL OPINION, THE LESION WAS LIKELY LOCATED IN THE UMBILICAL VEIN (NOT PLACENTAL VEIN), BASED ON THE TIMING OF THE EVENTS (BRADYCARDIA WITHIN 30 SECONDS). THE LESION WAS LIKELY CAUSED BY THE IUPC (INTRAUTERINE PRESSURE CATHETER) DEVICE. THE MOST REASONABLE CONDITIONS THAT WOULD LEAD TO AN UMBILICAL VEIN LESION BY THE IUPC DEVICE ARE DEVICE-RELATED (HARD IUPC TIP) OR APPLICATION-RELATED (FAILURE TO FOLLOW IFU). THE AVAILABLE INFORMATION DOES NOT SUPPORT THAT EITHER OF THESE CONDITIONS WERE PRESENT DURING THIS INCIDENT. THEREFORE, IT IS NOT KNOWN WHY THE IUPC CAUSED THE LESION IN THE UMBILICAL VEIN. AS A RESULT, WE ARE CONSIDERING THIS TO BE A MALFUNCTION FOR REPORTING PURPOSES ONLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN INCIDENT (DEATH OF A PATIENT) OCCURRED WHILE A M1333A KOALA TIP CATHETER WAS IN USE. IT HAS NOT BEEN CONFIRMED YET THAT IF THE DEVICE MALFUNCTIONED OR IF THE DEVICE WAS A CONTRIBUTING FACTOR THE PATIENT¿S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53624 NA NA HGS PHILIPS MEDICAL SYSTEMS M1333A NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Death| O