MAUDE Adverse Event Report: MVF DISPOSABLES/CLINICAL INNOVATIONS, LLC KOALA EXTERNAL; TRANSDUCER, PRESSURE, INTRAUTERINE

Lot Number 231411

Patient Problems Fetal Distress (1856); Uterine Perforation (2121)

Event Date 03/09/2024

Event Type  Injury  

Event Description

Uterine rupture after using iupc for amnioinfusion.Iupc placed at 0254.Amnioinfusion started at 0905 300 ml bolus at rate of 999ml/hr then 50 ml/hr.Was started approximately 90 minutes prior to identification of uterine rupture.No fluid returned from amnioinfusion, abdomen palpated soft between contractions.Urgent c/s due to concern for uterine rupture, exhibited change in sve and loss of ability to find fht with external and internal monitors.Surgeon noted placental fragments and fetal head palpable extrauterine consistent with uterine rupture.Therapy duration: 1.5 hour.Uterine activity, measurement of mvus.

• Brand Name: KOALA EXTERNAL
• Type of Device: TRANSDUCER, PRESSURE, INTRAUTERINE
• Manufacturer (Section D): MVF DISPOSABLES/CLINICAL INNOVATIONS, LLC
• MDR Report Key: 18897684
• MDR Text Key: 337785427
• Report Number: MW5152782
• Device Sequence Number: 1
• Product Code: HFN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/09/2024

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
• Device Lot Number: 231411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic