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

Model Number 6-820-00

Device Problem Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/25/2021

Event Type  Injury  

Manufacturer Narrative

On 1/5/2022, northgate technologies, inc was made aware of an alleged event involving an in-line warmer with nti part number 6-820-00; serial number (b)(4).The suspect device is currently anticipated for return for evaluation at manufacturer (northgate technologies, inc).Capa (b)(4) has been initiated and initial evaluation performed with additional communication/interview from the distributor amt vantage who has reported the complaint.The device history record for (b)(4) from november of 2018 ((b)(4)) was reviewed and the device passed all testing.Nothing out of the ordinary was noted.Preliminary capa (b)(4) evaluation is based on review of the device history records and communication received from the customer, the customer does not know how many autoclave cycles the warmer was run through.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 mis-alignment 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.When the warmer arrives at nti, it will be inspected to determine the nature of the malfunction.From the description, the nebulae i used with the warmer (b)(4) appeared to function normally- warned and alerted the user that in-line warmer malfunction, however, the alert was interpreted wrong by the staff and ignored during the entire procedure.It is unclear if the nebulae i will be returned for analysis.A follow up report will be filed with any additional findings when the unit has been returned to nti.

Event Description

On 1/5/2022 northgate technologies, inc was made aware of the alleged event on an in-line warmer, " laparoscopic hysterectomy was performed using the nebulae and the in line warmer.There was an issue with the in line warmer that was indicated on the nebulae.Unfortunately, the device was not disconnected and the cable became very hot to touch (which was only discovered at the end of the case).The patient was badly burned form the in line warmer cable." upon further follow up the burn was categorized as "2 degree burn to flank.About 4x4 cm.Flamozine cream to treat burns and a dressing was applied.The patient was discharged home the next day.".

Manufacturer Narrative

The nebulae i 50l insufflator (93631aej) was received by the manufacturer and passed all fqc for testing 3/18/22.Capa22002: testing of the suspect warmer with serial number (b)(6) showed that the 50l device recognized and detected that the inline warmer had a problem.The machine started beeping and flashing with the orange thermometer and yellow bell symbols in the display.Electrical testing using test fixtures 54-0240-1 and 54-0701 and digital multimeter showed the readings for all values except id resistor was out of specification.After slitting the silicone jacket, the sealing compound where the cable enters the cartridge was noted to be depleted, the braided shield was rusted and damaged (frayed/broken) and likely shorted the cable.The conclusion is the inline warmer overheated, and as a result, the thermal energy heated the outside surface of the sheath.Primary root cause: excessive bending and pulling that stresses the cable caused the internal insulations and wire to deteriorate and break exposing the wires.The red wire shorted to the ground when it was a plugged into the device which caused the warmer to overheat and burn the patient.Secondary root cause: the operator was not attending the alert, the flashing orange thermometer, and the yellow bell warnings symbols until the end of the procedure.Other factors: the age of the warmer, lack of inspection and tracking of the usage, lack of training, depleted potting around the cable, moisture gets into the gap and trap, screwing or unscrewing the cap end while holding the sheath instead, not carefully sliding in and out the end cap, may had contributed and propagated the damage to the insulation, shield, and wires (i.E.Wear and tear).The customer had rev.H of the manual that did not have the explicit notes below that were added to rev i to instruct what to do with a flashing orange thermometer alert."the flashing orange thermometer is an indication of a "fault condition".This condition will be accompanied by an audible alert.Please unplug and replace the in-line co2 gas warmer.If replacing the in-line co2 gas warmer does not remedy the orange flashing thermometer condition, please return the device that supports the gas warming feature to northgate technologies for service." a follow up report will be filed with any additional findings when the unit has been returned to nti.

Event Description

On 1/5/2022 northgate technologies, inc was made aware of the alleged event on an in-line warmer, ".Laparoscopic hysterectomy was performed using the nebulae and the in line warmer.There was an issue with the in line warmer that was indicated on the nebulae.Unfortunately, the device was not disconnected and the cable became very hot to touch (which was only discovered at the end of the case).The patient was badly burned from the in line warmer cable.".Upon further follow up the burn was categorized as "2 degree burn to flank.About 4x4 cm.Flamozine cream to treat burns and a dressing was applied.The patient was discharged home the next day.".

• Brand Name: IN-LINE GAS WARMER
• Type of Device: IN-LINE GAS WARMER
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer (Section G): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer Contact: todd gatto ; 1591 scottsdale court; elgin, IL 60123 ; 2248562250
• MDR Report Key: 13338935
• MDR Text Key: 287337864
• Report Number: 0001450997-2022-00001
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 00817183020233
• UDI-Public: 00817183020233
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K022052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2018
• 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
• Patient Outcome(s): Required Intervention