MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC KIWI COMPLETE VACUUM DELIVERY SYSTEM

Model Number	VAC-6000MTE
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Codes	Hematoma (1884); Cephalohematoma (2599)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical innovations is investigating the incident and requesting additional information on patient outcome.If any additional information is obtained, a follow-up report will be submitted.It has come to our attention that the wrong year was used in the submission number.
Event or Problem Description
Applied kiwi at the right flexion point for (b)(6) baby with oa presentation.Cup pressure was normal at the beginning as shown on monitor and suddenly pressure was dropped + cup dislodged with traction.Not a pop-off, (b)(6) spontaneous onset of labor, bmi 24.34 experienced user.Used forceps baby went to hdu for observation for hematoma.
Additional Manufacturer Narrative
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: one used kiwi was returned to ci for evaluation.Additionally, two sterile devices were also included.A complete visual inspection of the used device did not find any visual damage or noticeable defects.The device then underwent a series of function checks to simulate use.First, the vacuum cup was placed against a silicone pad and the handle was pumped to generate vacuum to the top end of the green zone (approximately 600 mmhg).The device generated vacuum normally, without any extra or modified effort.While at the generated vacuum level (approximately 600 mmhg), the device underwent further simulated use testing, where traction force of 30 lbs.(indicated by the scale label on the gauge) was applied 10 times to the device (the cup was held by hand, and the pump handle was pulled, with the connecting tube being perpendicular to the top of the vacuum cup).No leak was observed.Then the device was left at the current vacuum level for 10 minutes, to observe if any long-term leak was present.The kiwi vacuum gauge did not show any change from the original vacuum level from when the test started.Additional testing was done to determine if the device would fail with greater traction force applied during simulated use testing.The device was aggressively pulled above 40 lbs.(where the traction indicator spring is completely compressed and the indicator line can no longer show the level of force greater than 38 lbs.) for an additional 7 pulls over approximately 5 minutes of testing with the vacuum still applied, and the cup attached to the silicone pad.After the 6th pull a small vacuum leak began with full scale traction force applied (7th pull).With full traction force held (40 + lbs.) the device leaked off full vacuum over approximately 30 seconds.The complaint for the used device could not be confirmed.No defect was found with the device returned for analysis.Additional abusive testing caused the device to fail, far outside the scope of normal use.The two sterile devices were tested in an identical functional manner, except they were pulled to full spring compression (approximately 38 lbs.Traction force) instead of 30 lbs.Immediately after vacuum generation.At the end of the 10-minute test, the devices remained attached to silicone pads.Before the vacuum was released, one of the devices had traction applied of approximately 60 lbs.(held to the floor with foot and pulled by the handle) and the device did not fail or leak.No defect was found with either of the sterile devices that were returned for testing by the customer.Conclusion: the conclusion of our investigation indicates the returned used device and the 2 sterile unused kiwi cup 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 device, the vacuum was achieved normally, therefore the complaint is not confirmed.The cause is likely due to one or more of the following: 1) cannot achieve proper vacuum level because of placement or maternal or other tissue trapped between the cup and scalp, 2) device disengages due to misdirected traction, excessive traction force, improper placement, user fails to place non-pulling hand on cup during application of traction, or user fails to pump to proper vacuum level before use.Complaint is not confirmed.
Event or Problem Description
New information has been reported.It was learned the infant is fine.It was also not determined if the forceps or kiwi cup caused or contributed to this incident.

• Brand Name: KIWI COMPLETE VACUUM DELIVERY SYSTEM
• Common Device Name: VACUUM DELIVERY SYSTEM
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 8567034
• Report Number: 1722684-2019-00003
• Device Sequence Number: 16540808
• Product Code: HDB
• UDI-Device Identifier: 00814247020659
• UDI-Public: 00814247020659
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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 Expiration Date: 07/27/2020
• Device Model Number: VAC-6000MTE
• Device Lot Number: 181130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other