MAUDE Adverse Event Report: HUDSON 22MM HTD NIV CIRC KIT; HUMIDIFIER NEBULIZER KIT

Model Number	IPN913838
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be conducted since the lot number of the device was not provided.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "pediatric patient on trach collar was receiving 6lpm.The neptune alarmed and the nurse noticed that the circuit had melted near the patient temperature probe port.It was confirmed that the temperature probe at the patient wye was not connected to the circuit and they feel this may of caused the circuit to melt".It was reported that the circuit was replaced.No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one full 870-98kit circuit for investigation.During visual inspection one large melted section was observed.The melted section had melted all the way through the tubing.It was observed that there were no breaks or bunches of wires in the tubing.The heated wires used in this circuit were insulated with a clear plastic flexible insulator coating with blue stripes.The melted section of the tubing was located at 2.25" from the end without the heated wire.The melted portion of tubing measured approximately 4".The resistance of the circuit was measured to be 13.7 ohms, which is within specification of 12.8-14.3 ohms.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No issues or discrepancies were found which could potentially be related to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.The ifu for this product states, "do not place tubing on patient's skin.Do not cover tubing with sheets, blankets, towels, clothing, or other materials." the complaint of a breathing circuit melting has been confirmed.Since all heated wire circuit product codes are inspected 100% before leaving the manufacturing facility, it is unlikely that the failure was present at the time of release.A device history record review was performed with no evidence to suggest a manufacturing related issue.The root cause for the failure is unintentional user error.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "pediatric patient on trach collar was receiving 6lpm.The neptune alarmed and the nurse noticed that the circuit had melted near the patient temperature probe port.It was confirmed that the temperature probe at the patient wye was not connected to the circuit and they feel this may of caused the circuit to melt".It was reported that the circuit was replaced.No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: HUDSON 22MM HTD NIV CIRC KIT
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 11329896
• Report Number: 3004365956-2021-00036
• Device Sequence Number: 1151468
• Product Code: OGG
• UDI-Device Identifier: 14026704660466
• UDI-Public: 14026704660466
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN913838
• Device Catalogue Number: 870-98KIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 03/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HUDSON CONCHA NEPTUNE; HUDSON CONCHA NEPTUNE