BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIWI COMPLETE VACUUM DELIVERY SYSTEM

    MDR report key: 8479632 · Received April 3, 2019

    Report

    Report Number
    1722684-2019-00002
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 29, 2019
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    UDI-DI
    00814247020659
    PMA / PMN Number
    K981260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: THE DHR REVIEW INDICATES NO NCRS OR DEVIATIONS ASSOCIATED WITH THIS LOT. THIS LOT HAS MET THE SPECIFICATIONS OUTLINED FOR RELEASE. SAMPLE ANALYSIS: TWO USED DEVICES WERE RETURNED FOR EVALUATION. NEITHER OF THE DEVICES HAD ANY VISUAL DAMAGE OR ABNORMALITIES. BOTH DEVICES WERE FUNCTION CHECKED BY PLACING EACH CUP AGAINST A SILICONE PAD AND THE HANDLE WAS PUMPED TO GENERATE VACUUM TO THE TOP END OF THE GREEN ZONE (APPROXIMATELY 600 MMHG). BOTH DEVICES GENERATED VACUUM NORMALLY. WHILE AT THE GENERATED VACUUM LEVEL, BOTH DEVICES UNDERWENT SIMULATED USE TESTING, WHERE FULL SCALE (35 LBS) TRACTION FORCE WAS APPLIED 3 TIMES TO EACH DEVICE. AFTER NO ADVERSE EFFECTS WERE SEEN, EACH DEVICE WAS THEN LEFT AT THE CURRENT VACUUM LEVEL FOR 10 MINUTES. NEITHER DEVICE EXHIBITED ANY CHANGE IN THE VACUUM LEVEL. WAS OBSERVED. NO DEFECTS WERE FOUND ON EITHER DEVICE. RESULTS: THE USER COMPLAINT COULD NOT BE CONFIRMED. NO DEFECT WAS FOUND WITH EITHER DEVICE. . CONCLUSION: CONSIDERING THE FOLLOWING INFORMATION INCLUDED WITH THE COMPLAINT WHERE IT WAS REPORTED " KIWI'S POPPED OFF AFTER 1 PULL AND 2 OTHERS WHICH HAD BEEN THROWN OUT POPPED OFF ALSO" IT IS LOGICAL (BASED ON THE FUNCTIONAL OUTCOME OF THE PRODUCT EVALUATION) TO CONCLUDE THAT THE USER APPLIED EXCESSIVE FORCE, LEADING TO A POP-OFF OR THE DEVICE MAY HAVE BEEN PLACED WITH TISSUE TRAPPED UNDER THE CUP, LEADING TO A VACUUM LEAK DURING USE WHICH EVENTUALLY RESULTED IN A POP-OFF DUE TO LOW VACUUM. IT IS ALSO POSSIBLE THAT THE USER NEVER ACHIEVED THE PROPER LEVEL OF VACUUM BEFORE TRACTION WAS APPLIED. THE CONCLUSION OF OUR INVESTIGATION INDICATES THE RETURNED USED DEVICES FUNCTIONED AS EXPECTED AND APPROPRIATELY UNDER OUR TESTING CONDITIONS. PLEASE BE AWARE THERE ARE CERTAIN OBSTETRICAL FACTORS THAT MAY IMPACT ONE'S ABILITY TO OBTAIN OR MAINTAIN VACUUM ON THE FETAL HEAD DURING CLINICAL USE, SOME OF THESE ARE PREVENTABLE AND SOME ARE NOT. THE PREVENTABLE CAUSES INCLUDE: PROPER PLACEMENT OF THE CUP OVER THE FLEXION POINT, AVOIDING MATERNAL TISSUE, LIMITING TRACTION EFFORTS TO <25 LBS. OF FORCE, AVOIDING IMPROPER ANGLES OF TRACTION, AND ENCOURAGING GOOD MATERNAL EFFORT. THE NON-PREVENTABLE CAUSES INCLUDE: EXTREME MALPOSITION, EXCESSIVE CAPUT, HAIR AND/OR MOLDING. IN THE RETURNED DEVICES, THE VACUUM WAS ACHIEVED NORMALLY, THEREFORE THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REPORTED THAT SINCE MULTIPLE INSTURMENTS WERE USED, IT IS NOT CLEAR IF THE MATERNAL INJURY WAS DUE TO THE FORCEPS OR KIWICUP.

    Additional Manufacturer Narrative · 1

    CLINICAL INNOVATIONS IS INVESTIGATING THE INCIDENT. USER FACILITY DID REPORT THAT BOTH MOTHER AND BABY ARE DOING FINE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    2 X KIWIS DEFLATED NO CAPUT. IT IS NOT CLEAR IF HEMATOMA WAS FROM KIWICUP OR FORCEPS. IT WAS NOT A VISIBLE TEAR. MOTHER WENT TO HDU UNIT, DUE TO HEMATOMA, BOTH ARE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271224 KIWI COMPLETE VACUUM DELIVERY SYSTEM VACUUM DELIVERY SYSTEM HDB CLINICAL INNOVATIONS, LLC VAC-6000MTE 180824 00814247020659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other