MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. IN-LINE GAS WARMER

Model Number 6-820-00

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2023

Event Type  malfunction  

Event Description

On 09nov2023 northgate technologies inc.Was made aware of the alleged event that occurred in japan on (b)(6) 2023 where it was alledged "before patient use and during setting up, when the user connected the warmer with the nebulae i unit and he pushed start button, the warmer was smoking.The tag was cut out and the sn was unknown, but the warmer has been used for approx.100 times according to the staff of the hospital.Action: they used the other unit."no patient injury was reported, as this occurred during setup.

Manufacturer Narrative

On 11/09/2023, northgate technologies, inc was made aware of an alleged event involving an in-line warmer with nti part number 6-820-00; serial number unknown.The suspect device was returned for evaluation at manufacturer (northgate technologies, inc) under issue-2023-0054.The complaint was confirmed, the warmer exhibited many signs that it experienced an over temperature event (e.G., charred and melting components).The smoking, melting and charring of a warmer is not normal behavior of the device.The probable root cause is due to an incorrect orientation of the pins in the connector, the root cause of the over-heating was most likely due to misaligned pins on the connector assembly as a result of improper re-assembly or disengagement over time.A misaligned connector could cause an uncontrolled current to flow through the warmer resulting in overheating.The mis-alignment issue of the connector has been addressed in capa 17053 / ecn 4366.The collet nut is now secured to the connector using loctite during manufacturing as a preventive measure.The lot number is unknown but this device did not have loctite present on the connector which was implemented in 2019 under ecn 4366 to prevent the end user from disconnecting the connector and accidently reassembling the unit incorrectly at customer site.The warmer is validated for use up to 100 autoclave cycles, and use past this point can lead to degradation.The warmer ifu states to inspect the warmer for damage prior to use and not use damaged devices.Based on the date this warmer was manufactured, the warmer could easily exceed the life cycles (depending on use), resulting in abnormal behavior.The customer noted that the connector is disassembled during sterilization - this is not indicated in the ifu and is a known potential risk as there is a chance of misalignment when it is re-assembled which could cause the device to overheat in the sheath, thereby causing the skin to burn if / when the warmer is in direct contact with the skin.The product design was changed in 2019 to reduce the risk of the user disconnecting and misaligning the connector.Refer to attachment for the detailed evaluation.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: IN-LINE GAS WARMER
• Type of Device: IN-LINE GAS WARMER
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL
• Manufacturer (Section G): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL
• Manufacturer Contact: todd gatto ; 1591 scottsdale court; elgin, IL 60123
• MDR Report Key: 18297688
• MDR Text Key: 330561345
• Report Number: 0001450997-2023-00008
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K022052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6-820-00
• Device Catalogue Number: 6-820-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INSUFFLATOR.
• Patient Outcome(s): Hospitalization