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

Catalog Number 780-20

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medwatch number - (b)(4).Per phone discussion with ms.(b)(4) (risk mgt.), she indicates that the assumption is made that the red mark on the patient's arm was the result of contact with the melted circuit.No treatment needed.A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.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 is not available for evaluation.No photo available.Customer complaint cannot be confirmed based only on the information provided, to perform an 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 it 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 reports that the circuit melted.It is reported that the patient had a red mark on her upper left arm and no treatment was needed.

Manufacturer Narrative

(b)(4).The returned circuit was inspected visually confirming two melted spots in the circuit tube.Although the tube was melted there was no sign of heated wires burning/charring, and no sign of wire "gathering" or "bunching" that could have led to the melting.Functional testing determined the electrical resistance of the heated wire assembly to be 13.9ohms, well within the 12.8 - 14.3 ohms per specification.There were no manufacturing errors identified in the returned sample.The melt may have been due to a possible low flow through the assembly (must be a minimum of 3lpm for this style of circuit), possible covering of the circuit with a blanket, or pinching of the circuit which all can lead to a buildup of heat at a specific spot which could produce a melt in the circuit.This circuit was connected to a trach mask which means it was on continuous flow and the no information could be given as to the flow rate used.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.

Event Description

The customer reports that the circuit melted.It is reported that the patient had a red mark on her upper left arm and no treatment was needed.

• 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: 5500430
• MDR Text Key: 40328219
• Report Number: 3004365956-2016-00151
• 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: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 780-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2016
• 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
• Patient Age: 26 YR