BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIWI VACUUM ASSISTED DELIVERY SYSTEM

    MDR report key: 18556274 · Received January 22, 2024

    Report

    Report Number
    1722684-2024-00002
    Event Type
    Death
    Date Received
    January 22, 2024
    Date of Event
    July 9, 2022
    Report Date
    January 22, 2024
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    PMA / PMN Number
    K981260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVALUATION: NO PRODUCT EVALUATION COULD BE PERFORMED BECAUSE, TO OUR KNOWLEDGE, THE DEVICE WAS NOT RETAINED FOR INVESTIGATION AND NO PHOTOS WERE PROVIDED. AN ADDITIONAL INVESTIGATION WILL BE OPENED IF THE DEVICE IS RETURNED OR IF MORE DETAILS ARE PROVIDED. ADDITIONALLY, PER THE COMPLAINT DESCRIPTION, THE USER IS SAID TO HAVE "USED THE KIWI DEVICE FOR A TOTAL OF 47 MINUTES" AND "THE DEVICE WAS PLACED ON THE BABY'S HEAD AROUND 06:11 AM AND WAS REMOVED AROUND 07:01 AM." PER CURRENT AND PAST REVISIONS OF THE KIWI INSTRUCTIONS FOR USE (IFU), FAILURE OF EFFORTS AFTER 20 MINUTES IS LISTED AS AN ADDITIONAL CONDITION FOR CLOSE OBSERVATION AND ABANDONMENT OF VACUUM DELIVERY SHOULD BE CONSIDERED IF NO DESCENT (PROGRESS) OF THE HEAD OCCURS AFTER 2 TRACTIONS (IFU ATTACHED TO INVESTIGATION RECORD). INVESTIGATION DESCRIPTION: THE LOT NUMBER IS UNKNOWN, THEREFORE, THE NUMBER OF MFG CAUSED DEVICES FIELD AND DHR REVIEW SECTION WILL REMAIN BLANK. THIS SECTION WILL BE UPDATED IF LOT INFORMATION IS PROVIDED AT A LATER DATE. RISK ASSESSMENT: PER FMEA (B)(4), THE COMPLAINT MAY BE ASSOCIATED WITH THE FOLLOWING POTENTIAL FAILURE MODE: NOTE: POTENTIAL FAILURE MODES 1 - 6 SHARE THE SAME THE SAME POTENTIAL CAUSES AND ARE GROUPED TOGETHER IN THE LIST BELOW. POTENTIAL FAILURE MODE 7 IS LISTED SEPARATELY. POTENTIAL FAILURE MODE 1: USER FAILS TO FOLLOW RECOMMENDATIONS OF ABANDONMENT; 1) IF NO DESCENT (PROGRESS) OF THE HEAD OCCURS AFTER 2 TRACTIONS. 2) IF DELIVERY IS NOT ACHIEVED OR IMMINENT AFTER 4 TRACTIONS, OR 3) IF THE VACUUM CUP DETACHES ("POPS-OFF") TWICE. POTENTIAL EFFECTS: EXCESSIVE ATTEMPTS LEAD TO FETAL OR MATERNAL INJURY POTENTIAL FAILURE MODE 2: USER FAILS TO LOCATE THE FLEXION POINT AND LOCATES THE DEVICE ON A DIFFERENT AREA. POTENTIAL EFFECTS: USING THE DEVICE ON A DIFFERENT LOCATION OTHER THAN FLEXION POINT CAUSE INAPPROPRIATE USE OF THE DEVICE. POTENTIAL FAILURE MODE 3: USER LOCATES THE FLEXION POINT BUT FAILS TO NOTE DISTANCE WHERE FINGER MEETS INTROITUS (FAILS TO CALCULATE THE DISTANCE). POTENTIAL EFFECTS: USER INSERTS THE DEVICE ON A DIFFERENT LOCATION CAUSING INAPPROPRIATE USE OF DEVICE. POTENTIAL FAILURE MODE 4: USER FAILS TO PUSH CUP POSTERIORLY ALONG MATERNAL MIDLINE OVER FLEXION POINT. POTENTIAL EFFECTS: USER INSERTS THE DEVICE ON A DIFFERENT LOCATION CAUSING INAPPROPRIATE USE OF DEVICE. POTENTIAL FAILURE MODE 5: USER FAILS TO ESTABLISH APPROPRIATE LEVEL (450 - 600 MMHG) OF VACUUM. POTENTIAL EFFECTS: THE DEVICE DISENGAGES/POPS OFF THE FETAL HEAD. POTENTIAL FAILURE MODE 6: USER CREATES VACUUM BUT FAILS TO EXCLUDE ANY MATERNAL TISSUE. POTENTIAL CAUSE: FAILURE TO EXCLUDE ANY MATERNAL TISSUE CAUSES CUP DETACHMENT/POP-OFF. HARM 1: HEMATOMA, SEVERITY: 4, POTENTIAL CAUSE: LACK OF ATTENTION, NOT QUALIFIED PERSONNEL, PROBABILITY OF OCCURRENCE: 1, RISK IS CONSIDERED "MONITOR". HARM 2: ABRASION, SEVERITY: 2, POTENTIAL CAUSE: LACK OF ATTENTION, NOT QUALIFIED PERSONNEL, PROBABILITY OF OCCURRENCE: 1, RISK IS CONSIDERED "ACCEPTABLE". HARM 3: FRACTURE, SEVERITY: 3, POTENTIAL CAUSE: LACK OF ATTENTION, NOT QUALIFIED PERSONNEL, PROBABILITY OF OCCURRENCE: 1, RISK IS CONSIDERED "ACCEPTABLE". HARM 4: LACERATION, SEVERITY: 3, POTENTIAL CAUSE: LACK OF ATTENTION, NOT QUALIFIED PERSONNEL, PROBABILITY OF OCCURRENCE: 1, RISK IS CONSIDERED "ACCEPTABLE". HARM 5: DEATH, SEVERITY: 5, POTENTIAL CAUSE: LACK OF ATTENTION, NOT QUALIFIED PERSONNEL, PROBABILITY OF OCCURRENCE: 1, RISK IS CONSIDERED "MONITOR". POTENTIAL FAILURE MODE 7: USER FAILS TO INITIATE TRACTION ALONG AXIS OF PELVIS, POTENTIAL EFFECTS: EXCESSIVE FORCE IS USED, HARM 1: HEMATOMA, SEVERITY: 4, POTENTIAL CAUSE: USER MOVES HANDLE UP AND DOWN WHILE PULLING; USER MOVES HANDLE SIDE TO SIDE WHILE PULLING; NOT QUALIFIED PERSONNEL, PROBABILITY OF OCCURRENCE: 1, RISK IS CONSIDERED "MONITOR". HARM 2: ABRASION, SEVERITY: 2, POTENTIAL CAUSE: USER MOVES HANDLE UP AND DOWN WHILE PULLING; USER MOVES HANDLE SIDE, TO SIDE WHILE PULLING; NOT QUALIFIED PERSONNEL, PROBABILITY OF OCCURRENCE: 1, RISK IS CONSIDERED "ACCEPTABLE". HARM 3: FRACTURE, SEVERITY: 3, POTENTIAL CAUSE: USER MOVES HANDLE UP AND DOWN WHILE PULLING; USER MOVES HANDLE SIDE TO SIDE WHILE PULLING; NOT QUALIFIED PERSONNEL, PROBABILITY OF OCCURRENCE: 1, RISK IS CONSIDERED "ACCEPTABLE". HARM 4: LACERATION, SEVERITY: 3, POTENTIAL CAUSE: USER MOVES HANDLE UP AND DOWN WHILE PULLING; USER MOVES HANDLE SIDE TO SIDE WHILE PULLING; NOT QUALIFIED PERSONNEL, PROBABILITY OF OCCURRENCE: 1, RISK IS CONSIDERED "ACCEPTABLE". HARM 5: DEATH, SEVERITY: 5, POTENTIAL CAUSE: USER MOVES HANDLE UP AND DOWN WHILE PULLING; USER MOVES HANDLE SIDE, TO SIDE WHILE PULLING; NOT QUALIFIED PERSONNEL, PROBABILITY OF OCCURRENCE: 1, RISK IS CONSIDERED "MONITOR", ROOT CAUSE ANALYSIS, A ROOT CAUSE CANNOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. USER ERROR OR DEVICE MALFUNCTION CANNOT BE RULED OUT AS POTENTIAL ROOT CAUSES.

    Description of Event or Problem · 0

    IN THE CUSTOMERS WORDS: ON (B)(6) 2022, A FEMALE CAME IN FOR SCHEDULED INDUCTION DUE TO HIGH BLOOD PRESSURE. ON (B)(6) 2022, AFTER TWO HOURS OF PUSHING OFF AND ON DR. (B)(6) WAS CALLED INTO THE ROOM TO ASSIST. DR. (B)(6) USED THE KIWI VACUUM DEVICE DURING THE DELIVERY. THE DEVICE WAS PLACED ON THE BABY'S HEAD AROUND 06:11 AM AND WAS REMOVED AROUND 07:01 AM. THE DOCTOR USED THE KIWI DEVICE FOR A TOTAL OF 47 MINUTES. "THE BABY WAS TRANSPORTED TO (B)(6) HOSPITAL ON (B)(6) 2022 , IN (B)(6). THE BABY WAS FOUND TO HAVE A LARGE SUBDURAL HEMATOMA AND WAS FLOWN TO (B)(6) HOSPITAL A FEW HOURS AFTER ARRIVING AT (B)(6). THE BABY DIED ON (B)(6) 2022."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422077 KIWI VACUUM ASSISTED DELIVERY SYSTEM FETAL VACUUM EXTRACTOR HDB CLINICAL INNOVATIONS, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death