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

Model Number	VAC-6000M
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hematoma (1884)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Follow has been sent to the initial reporter, awaiting a response.If a response is received a follow up report will be filed.An investigation was conducted the results are below: the complaint is not confirmed.No product evaluation could be performed because the device was not returned and no photos were provided.Potential failure mode: user fails to follow recommendations of abandonment; 1) if no descent (progress) of the head occurs after 2 tractions, 2) if delivery is not achieved or imminent after 4 tractions, or 3) if the vacuum cup detaches ("pops-off") twice.Potential effect: excessive attempts lead to fetal or maternal injury.This could lead to the following harms: harm 1: hematoma; severity: 4; potential cause: lack of attention, not qualified personnel; probability of occurrence: 1; risk is considered "monitor." harm 2: death; severity: 5; potential cause: lack of attention, not qualified personnel; probability of occurrence: 1; risk is considered "monitor." harm 3: fracture; severity: 3; potential cause: lack of attention, not qualified personnel; probability of occurrence: 1; risk is considered "acceptable." harm 4: abrasion; severity: 2; potential cause: lack of attention, not qualified personnel; probability of occurrence: 1; risk is considered "acceptable." harm 5: laceration; severity: 3; potential cause: lack of attention, not qualified personnel; probability of occurrence: 1; risk is considered "acceptable." no root cause can be determined because the complaint is not confirmed.
Event or Problem Description
In the customers words: "38.2 week gestation delivery to type 1 diabetic mom.Difficult vacuum assisted delivery with approximately 8 vacuum pulls.Apgars 4, 7, 8, resuscitation needed ppv x 5 minutes then cpap x8 minutes.Observed in nursery for grunting x4 hours then released to floor.Babe had poor feeding after delivery.Babe discharged after 36 hours at request of parents.Babe remained poor feeding at home and continued to lose weight on checks in the community.Babe was admitted into hospital with high bili level and poor weight gain.On examination of poor feeding and lethargy with history of kiwi assisted delivery a head xray and ct were ordered.The ct showed fractures of the right parietal, left frontal and temporal bones.Bilateral subdural temporal hematoma, larger on the right and subdural hematoma is also present on the tentorium cerebelli.".

• Brand Name: KIWI VACUUM 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: 15540753
• Report Number: 1722684-2022-00008
• Device Sequence Number: 7046077
• Product Code: HDB
• UDI-Device Identifier: 00814247020000
• UDI-Public: 00814247020000
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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-6000M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 10/04/2022
• 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
• Patient Sex: Unknown