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

Model Number	VAC-6000ME
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Shock, Traumatic (2268)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical innovations is gathering more information on the patient condition and around the event.If any additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
My patient was already fully effaced, head is on +1 but with severe fetal distress.So i decided to use the kiwi for faster delivery.As i applied the vacuum the head was not working as the wire between the handle and the cap was completely broken.Causing trama to the baby.
Additional Manufacturer Narrative
The complaint device was returned.In visual exam some slight deformation was seen in the edge due to traction force during use.It was found that the crimp appears to have been manufactured and processed correctly.The back side of the connector has some deformation due to traction force during use.The cable anchor has some deformation caused by the friction of the cable sliding on the surfaces after it broke.The investigation has determined it is believed that an incorrect air pressure setting caused an inconsistent crimp for some devices during 07/02/2018-08/10/2018.Further testing was performed and there were no failures to meet design requirements during testing but one lot had more variation in the data then normal.It is believed that when devices from the suspect lot are used with traction force greater then recommended, the device may experience unexpected failure.Testing did however find all devices from the suspect lot exceeded the kiwi design specification of 40 lbs.Of force.It was found that the risk of breaking the device is mitigated when these kiwi devices are not used with excessive force.No action will be taken as the manufacturing error has been corrected.Testing found all samples of this lot number met the design requirement.The complaint was found to be confirmed.Quality will continue to monitor all incoming complaints for any spike or increased trend to indicate if there is any further concern.

• Brand Name: KIWI OMNI 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: 8425692
• Report Number: 1722684-2019-00001
• Device Sequence Number: 11344667
• Product Code: HDB
• UDI-Device Identifier: 00814247020635
• UDI-Public: 00814247020635
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VAC-6000ME
• Device Lot Number: 181054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/12/2019
• 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