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

Model Number	VAC-6000MTE
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Codes	Hematoma (1884); Vaginal Mucosa Damage (2124)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Event or Problem Description
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
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.

• 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: 8479632
• Report Number: 1722684-2019-00002
• Device Sequence Number: 13766546
• 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): 04/29/2019

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: 06/01/2020
• Device Model Number: VAC-6000MTE
• Device Lot Number: 180824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 04/29/2019
• 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