MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. NEBUALE I; INSUFFLATOR

Model Number 6-810-00

Device Problem Overheating of Device (1437)

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

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

The warmer, nti part number 6-810-00; serial number unknown is in transit to nti from (b)(6) distributor amco, inc.The product has currently been stopped in the us by customs and the product will be inspected if/when released to nti.The serial number of the device involved in the complaint is unknown as the customer removed the serial tag from the product.The last time this part number was produced was in 2015, and the device has a 6 year shelf life.Based on images and questions/answers provided by the distributor, nti has confirmed there may be evidence of a high temperature event (e.G., report by the distributor that the outer sheath has evidence of melted drapery, the tubing set connected to the end of the warmer is discolored).There have been no other complaints reported to nti for this device.Nti has initiated nonconformance (b)(4) to investigate this event further.Any additional findings will be updated via a follow-up report.

Event Description

On 10/05/2020, northgate technologies was made aware of an issue with an in-line warmer from distributor amco in japan where it was alleged, "the customer smelled something burning and found smoke.Overlapped three drapes on the patient burn a hole, but there was no adverse event.The top of the sheath of the warmer broke." there was no adverse effect reported.

Manufacturer Narrative

The warmer, nti part number 6-810-00; serial number unknown, was evaluated under nti capa 20061.The serial number of the device involved in the complaint is unknown as the customer removed the serial tag from the product.Inspection of the warmer confirmed that the collet nut on the connector was very loose and not completely screwed down to the connector housing.If the collet nut on the lemo connector is not fully screwed down, there is a potential that the contact pin assembly within the connector can be rotated and not properly aligned with the keying on the connector housing.This may cause a pin misalignment with respect to the connector index position.The root cause for the overheating of the warmer is most likely caused by pin misalignment due to a loose collect nut.Since the warmer has undergone over 100 autoclave sterilization cycle, the repeated usage and thermal cycling probably contributed to the collet nut coming loose.Nti manufactured (b)(4) 4-pin warmers in the past and this is the first occurrence of this failure that nti has been made aware of.The 4-pin warmer is no longer manufactured and has not been manufactured since 2015.The normal life expectancy of a warmer is 100 cycles (procedures) of sterilization so the chance that other 4-pin warmers still being out in the field is remote.An analysis of complaint data has shown that the occurrence rate of this type of failure has been very low in the warmer product line.This is the first complaint nti has received on a 4-pin warmer.

• Brand Name: NEBUALE I
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• MDR Report Key: 10788848
• MDR Text Key: 214780204
• Report Number: 0001450997-2020-00007
• 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,foreign
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6-810-00
• Device Catalogue Number: 6-810-00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1