MAUDE Adverse Event Report: CLINICAL INNOVATIONS KIWI VACUUM ASSISTED DELIVERY SYSTEM; VACUUM ASSISTED DELIVERY DEVICE

Model Number	VAC-6000MT
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	02/13/2023
Type of Reportable Event	Death
Event or Problem Description
In the customer's words: "operative vaginal delivery via kiwi vacuum.Infant with subgaleal bleed".
Additional Manufacturer Narrative
Note: several follow up attempts have been made with the hospital but clinical innovations has not been able to get in contact with the initial reporter.Product evaluation: the complaint is not confirmed.No product evaluation could be performed because the device was not returned and no photos were provided by the customer.Investigation description: a dhr review could not be performed because the lot number is unknown risk assessment: per fmea risk-0029 rev.02, 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: 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: 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.

• Brand Name: KIWI VACUUM ASSISTED DELIVERY SYSTEM
• Common Device Name: VACUUM ASSISTED DELIVERY DEVICE
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: zulmar molina ; 747 w 4170 s; murray, UT 84123
• MDR Report Key: 16546287
• Report Number: 1722684-2023-00003
• Device Sequence Number: 17644276
• Product Code: HDB
• UDI-Device Identifier: 00814247020642
• UDI-Public: 00814247020642
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: VAC-6000MT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown