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

Lot Number 18099145

Device Problems Fluid/Blood Leak (1250); Product Quality Problem (1506); Defective Component (2292)

Patient Problem Aspiration/Inhalation (1725)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

The reported symptom that the cartridge of patient breathing circuit 18099145 overfilled could not be verified and was not reproduced as reported.The cartridge low and high water level detection circuitry was verified to be operating correctly and the cartridge was verified to fill to the correct levels with the water never exceeding the mid-level sense pin.The reported symptom that the cartridge was leaking water could be verified and was reproduced exactly as reported.An improper gasket to heater cup seal allowed a slight continuous water leak.

Event Description

Jet and circuit were running on baby normally.User facility reported that cartridge overfilled and delivered water to patient.Patient was suctioned and there was no injury.The user facility also reported that water was leaking out of the bottom of the cartridge.

• Brand Name: BUNNELL PATIENT CIRCUIT
• Type of Device: BUNNELL PATIENT BREATHING CIRCUIT
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale drive; salt lake city UT 84115
• Manufacturer (Section G): BUNNELL, INC.; 436 lawndale drive; salt lake city UT 84115
• Manufacturer Contact: curtis olsen ; 436 lawndale drive; salt lake city, UT 84115 ; 8014670800
• MDR Report Key: 8636963
• MDR Text Key: 146247666
• Report Number: 1719232-2019-00001
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 18099145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2018
• 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