BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIWI VACUUM ASSISTED DELIVERY SYSTEM

    MDR report key: 19037636 · Received April 3, 2024

    Report

    Report Number
    1722684-2024-00006
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    March 4, 2024
    Report Date
    April 3, 2024
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    UDI-DI
    00814247020635
    PMA / PMN Number
    K981260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP IS BEING ATTEMPTED, NO RESPONSE RECIEVED TO DATE. INVESTIGATION DESCRIPTION A DHR REVIEW WAS PERFORMED AND NO DEVIATIONS OR NCRS WERE FOUND TO BE INITIATED FOR LOT# 230998. RISK ASSESSMENT PER FMEA-00138 [B], THE COMPLAINT MAY BE ASSOCIATED WITH THE FOLLOWING POTENTIAL FAILURE MODE: 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 ESTABLISH APPROPRIATE LEVEL (450 - 600 MMHG) OF VACUUM. POTENTIAL EFFECTS: THE DEVICE DISENGAGES/POPS OFF THE FETAL HEAD. POTENTIAL FAILURE MODE 3: 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". ROOT CAUSE ANALYSIS: A ROOT CAUSE COULD NOT BE DETERMINE BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. USER ERROR AND DEVICE MALFUNCTION CANNOT BE RULED OUT AS POTENTIAL ROOT CAUSES.

    Description of Event or Problem · 0

    IN THE CUSTOMERS WORDS: "SCALP LESIONS AFTER USE ON TWO BABIES" "THE BABY'S SCALP WAS ALMOST TORN OFF. THE CHILD HAD TO BE TRANSFERRED TO A NEONATAL UNIT AFTER BIRTH. HE IS NOW BEING MONITORED BY A SPECIALIST FOR ANY NEUROLOGICAL AFTER-EFFECTS." FOLLOW UPS HAVE BEEN ATTEMPTED BUT TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608000 KIWI VACUUM ASSISTED DELIVERY SYSTEM FOETEL VACUUM ASSISTED DELIVERY DEVICE HDB CLINICAL INNOVATIONS, LLC VAC-6000ME 230998 00814247020635

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization