MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CIRCUIT ACCESSORY,HEATED WIRE, INSPIRAT; VENTILATOR CIRCUIT

Catalog Number 780-20

Device Problem Melted (1385)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 04/24/2015

Event Type  malfunction  

Event Description

The customer alleged that the circuit melted.The device was not in use on a pt at the time of the alleged issue.No report of a pt injury or harm.

Manufacturer Narrative

Qn#(b)(4).It is unk if the device sample is available for eval.A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not received 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 time since the device sample or a picture of it is not available for eval.Customer complaint cannot be confirmed based only on the info 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 at the facility nor is being manufactured at the time.If device sample becomes available at a later date this complaint will be re-opened.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that several sections of the corrugated tubing were melted.No issues were found with the assembly of the heated wires.They were evenly distributed along the corrugated tubing and were assembled according to specification.The heated wires were disassembled in order to inspect the wires for exposed wire or knots, but no damages or knots were found.The total length of heater wire assembly was measured and it was found to be within specification.Functional testing was performed and no issues were detected.Based on the investigation performed, the reported complaint was confirmed.Although the complaint was confirmed, a root cause could not be determined.There were no issues found with the assembly of the heated wires, and they were evenly distributed along the corrugated tubing.The product ifu (instructions for use) states several warnings in order to avoid overheating the circuit.

Event Description

The customer alleges that the circuit melted.The device was not in use on a patient at the time of the alleged issue.No report of a patient injury or harm.

• Brand Name: HUDSON CIRCUIT ACCESSORY,HEATED WIRE, INSPIRAT
• Type of Device: VENTILATOR CIRCUIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 8827 5; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4771451
• MDR Text Key: 5776547
• Report Number: 3004365956-2015-00142
• Device Sequence Number: 1
• Product Code: CAG
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 780-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2015
• 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