MAUDE Adverse Event Report: CLINICAL INNOVATIONS KIWI VACUUM DELIVERY SYSTEM; FETAL VACUUM EXTRACTOR

Model Number	VAC-6000MTE
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/06/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Clinical innovations is attempting to gather as much information as possible regarding this event.If any more information becomes available, a follow up report will be submitted.
Event or Problem Description
Description provided by the customer: placed kiwi.With the first traction the handle separated.Vacuum was not released spontaneously.Tried another traction: cup popped off.Vacuum was chosen out of fetal urgency.Following to this section vacuum failed (not sure what is meant here exactly).Suspicion of anemia child because of hematoma on the head.Baby died after reanimation.
Additional Manufacturer Narrative
Device investigation attached as a separate document.
Event or Problem Description
Description provided by the customer and answers to follow up questions placed kiwi.With the first traction the handle separated.Vacuum was not released spontaneously.Tried another traction: cup popped off.Vacuum was chosen out of fetal urgency.Following to this section vacuum failed (not sure what is meant here exactly).Suspicion of anemia child because of hematoma on the head.Baby died after reanimation.Research will follow.Was the infant born deceased and resuscitated? the neonate has been resuscitated; as (b)(6) 2023.Gestational age of infant gestational age 38 weeks and 2 days position and station of infant at time of vacuum placement bony part just on h3 with position of analv.Reason for vacuum placement--i know it says fetal urgency--was there concern with the fetal monitor tracing? if so, why (prolonged deceleration, etc)? suspected fetal distress: abnormal ctg with tachycardia, decreased variability and complicated decelerations.In addition, mother suddenly had a fever to 39.2 rectal.How long was the vacuum on the fetal head? 11 minutes if it was a kiwi mt device, did they note the pulling force on the traction force indicator with the 2 pulls? we are not used to noting the pulling force in the file after the 2nd pull, did they proceed to c/s or did the baby deliver vaginally? we pushed the caput and decided on a secondary sectional.The or team stood by.Were there any neonatal complications that were identified during pregnancy no.She was initiated because of prolonged broken membranes.Were there any complications identified with the placenta? the final pathology results of the placenta will follow.There were no clots visible behind the placenta during the section, so no suspicion of an abruption.

• Brand Name: KIWI VACUUM DELIVERY SYSTEM
• Common Device Name: FETAL VACUUM EXTRACTOR
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• MDR Report Key: 11695444
• Report Number: 1722684-2021-00003
• Device Sequence Number: 19741567
• Product Code: HDB
• UDI-Device Identifier: 00814247020659
• UDI-Public: 00814247020659
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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: 04/15/2022
• Device Model Number: VAC-6000MTE
• Device Lot Number: 192343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 10/07/2021
• 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: Death