BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIWI VACUUM DELIVERY SYSTEM

    MDR report key: 6062728 · Received October 27, 2016

    Report

    Report Number
    1722684-2016-00003
    Event Type
    Death
    Date Received
    October 27, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 27, 2016
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    PMA / PMN Number
    K981260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBGALEAL HEMORRHAGES ARE A RARE AND KNOWN RISK FACTOR FOR ANY VACUUM-ASSISTED VAGINAL DELIVERIES. RISK FACTORS FOR THIS TYPE OF HEMORRHAGE INCLUDE: NULLIPARITY, MALPOSITION, MISPLACEMENT OF THE CUP, PROLONGED TRACTION EFFORTS, AND POP-OFFS/DETACHMENT OF THE VACUUM CUP. AFTER THE REPORT WAS RECEIVED BY CLINICAL INNOVATIONS AND OUR DISTRIBUTOR IN (B)(4) HAVE MADE MULTIPLE ATTEMPTS TO GATHER MORE INFORMATION ON THE INCIDENT. AT THIS MOMENT THE HOSPITAL DOES NOT WANT TO RELEASE ANY INFORMATION UNTIL THEIR INTERNAL INVESTIGATION IS COMPLETED SOMETIME IN DECEMBER.

    Description of Event or Problem · 1

    ON (B)(6) 2016 CLINICAL INNOVATIONS WAS INFORMED OF A FETAL DEATH ASSOCIATED WITH A KIWI DEVICE. THE REPORT STATES THAT "A KIWI VACUUM DELIVERY SYSTEM WAS USED WITH ONE TRACTION THEN FAILED, APPLICATION OF NEVILLE-BARNES FORCEPS, THE SCALP SHOWED SOME BRUISING AND ABRASIONS" SUGGESTING POTENTIAL TRAUMA FROM THE VACUUM AND/OR FORCEPS. AT AUTOPSY A SUBGALEAL HEMORRHAGE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713870 KIWI VACUUM DELIVERY SYSTEM VACCUM DELIVERY SYSTEM HDB CLINICAL INNOVATIONS, LLC UKNOWN UKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 1 HR Death