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

Model Number	VAC-6000MT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Encephalopathy (1833); Intracranial Hemorrhage (1891)
Date of Event	07/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint is not confirmed.No product evaluation could be performed because the device was not returned and no photos were provided.A new investigation will be opened if/when the device is received.Per fmea risk-0029 rev.02, the complaint may be associated with the following potential failure mode: potential failure mode: user creates vacuum but fails to exclude any maternal tissue potential effects: failure to exclude any maternal tissue causes air/vacuum leak harm 1: delayed procedure severity: 1 potential cause: lack of attention, not qualified personnel probability of occurrence: 1 risk is considered "acceptable" harm 2: delayed procedure with fetal distress severity: 4 potential cause: lack of attention, not qualified personnel probability of occurrence: 1 risk is considered "monitor" no root cause could be determined because the complaint was not confirmed.
Event or Problem Description
In the customers word: "the kiwi vaccum device was not able to maintain suction pressure after pumped up to 65kpa, creates hissing sound and suction pressure quickly reduce down to 15kpa"."2nd kiwi vaccum device need to be used to effect delivery of the baby and this caused extensive subaponeurotic haemorrhage (sah) and hypoxic ischaemic encephalopathy (hie)" "vaccum assisted delivery for fetal bradycardia"."1st kiwi vaccuum device applied at 0215h, tested prior to application on fetal head and suction present, able to create suction pressure up to 65kpa however upon traction noted hissing sound and noticed suction pressure dropped to 15kpa, repeated pump suction attempted but similar problem.2nd kiwi device was obtained, tested and functioning well, applied at 0218h, suction maintained and successful delivery at 0222h"."baby was born pale requiring inotrope support due to extensive sah, also required packed cell and fresh frozen plasma transfusion.Also sustained hie grade 2".

• Brand Name: KIWI VACUUM ASSISTED DELIVERY SYSTEM
• Common Device Name: FETAL VACUUM EXTRACTOR
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: kellie stefaniak ; 747 w 4170 s; murray, UT 84123 ; 8012606079
• MDR Report Key: 15321973
• Report Number: 1722684-2022-00007
• Device Sequence Number: 14754041
• Product Code: HDB
• UDI-Device Identifier: 00814247020642
• UDI-Public: 00814247020642
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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
• Device Lot Number: 214646
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/30/2022
• 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: Hospitalization; Other; Required Intervention
• Patient Sex: Unknown