MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CIRCUIT ACCESSORY,HEATED WIRE, INSPIRAT; RESPIRATORY GAS HUMIDIFIER

Catalog Number 780-20

Device Problem Overheating of Device (1437)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not received yet at our facility.A device history record review could not be conducted since the lot number was not provided.No corrective action can be established at this moment since the device sample or a picture is not available for evaluation.Customer complaint cannot be confirmed based only on the information provided, to perform a proper investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility neither is being manufactured at the time.If the device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the circuit is hot.The nurse noted that the circuit was against the patient's leg and there was redness noted on the patient's skin at the contact site.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual inspection was performed and it was observed that damage caused by the melting/over heating to the circuit was extensive for approximately 5-6 inches on the blue corrugated tubing.The melting was so extreme in one area of the tubing that the plastic actually folded back exposing the heated wires.It was also noted that in one section of the damaged tube the heated wire melted so much of the corrugated plastic it encapsulated a strand of the heated wire.The heated wire was not "bunched" or "gathered" anywhere along the corrugated tubing.The heated wire was supported correctly on both ends of the breathing tube.The actual resistance value was measured at 14.1 ohms, which is well within specification.Based on the sample returned, the reported complaint was confirmed.This kind of melting is usually associated with external causes being the catalyst for the damage.In this case the breathing limb could have been covered with bed linen, or could have been up against something that could not allow for proper ventilation and cooling.The visual inspection and electrical measurement values do not support a product/manufacturing defect.Other remarks: a conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.

Event Description

The customer alleges that the circuit is hot.The nurse noted that the circuit was against the patient's leg and there was redness noted on the patient's skin at the contact site.The patient's condition is reported as fine.

• Brand Name: HUDSON CIRCUIT ACCESSORY,HEATED WIRE, INSPIRAT
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5551773
• MDR Text Key: 41997499
• Report Number: 3004365956-2016-00186
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 780-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1