MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL, INC.; PATIENT CIRCUIT

Model Number 00212

Device Problem Overfill (2404)

Patient Problems Aspiration/Inhalation (1725); Bradycardia (1751); Hypoxia (1918)

Event Date 05/14/2015

Event Type  Injury  

Event Description

After a patient was set up on the life pulse hfv the patient circuit humidifier cartridge overfilled, resulting in water entering the tubing and reaching the baby.The baby's heart rate and blood oxygenation went down.The therapist immediately disconnected, suctioned, and supported the patient.The circuit was changed.The new circuit functioned normally.Patient was stabilized following circuit change and restart of life pulse.The bunnell, inc.Clinical hotline was not called at the time of the issue.

Manufacturer Narrative

The reported symptom that the patient circuit (lot number 13065509) humidifier cartridge overfilled and delivered water to the patient could not be verified and was not reproduced.Repeated draining and filling of the cartridge throughout a 7 day continuous operational testing period always resulted in consistent mid-level fill and pump inhibit operation with no overfill condition observed.No operational issues were observed with this patient circuit from lot number 13065509.

• Brand Name: BUNNELL, INC.
• Type of Device: PATIENT CIRCUIT
• Manufacturer (Section D): BUNNELL, INC.; salt lake city UT
• Manufacturer Contact: curtis olsen ; 436 lawndale dr.; salt lake city, UT 84115 ; 8014670800
• MDR Report Key: 4879065
• MDR Text Key: 6041311
• Report Number: 1719232-2015-00004
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00212
• Device Lot Number: 13065509
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention