MAUDE Adverse Event Report: TELEFLEX HUDSON CIRCUIT, HTD DUAL LIMB WITH WATER TRAPS; BREATHING CIRCUIT

Catalog Number 780-36

Device Problem Melted (1385)

Patient Problem Death (1802)

Event Date 05/28/2014

Event Type  Death  

Event Description

The event is reported as: the customer alleges that the staff found a large amount of blood in the expiratory tubing/limb as well as a partially melted circuit.The inspiratory limb was also saturated with blood.The pt expired.

Manufacturer Narrative

The information documented was provided by (b)(6) - quality compliance and safety, supervisor from the user facility.Ms (b)(6) indicates that she did not think that the melted circuit had any effect on the outcome of the pt.She also states that her concern was that a death did occur and a teleflex product was part of the medical device configuration at the time of the pt's death.The claim was confirmed of a melt in the tubing.An incomplete circuit was received.Only 1/2 of one limb was received.It cannot be determined if it is the inspiratory or expiratory limb.The heated wires were cut so the resistance cannot be measured.The melt was 6 inches from the water trap.The melt was approximately 2 inches long.With only a part of the circuit received, it cannot be determined what caused the melt.A sharp edge to the melted section does indicate that the tubing may have been pinched at the melt location.A dhr (device history record) review could not be conducted since the lot number was not provided.However, an investigation was performed on material from production line.The product related to this complaint is (b)(4) (circuit, htd dual limb with water traps w/o).This product is conformed with subassemblies that contains two resistance wires p/n 11735-01 and 11735-02.Samples from the warehouse of teleflex, (b)(4) of these subassemblies were visually inspected and no knots or damage were found that can lead to this issue.The overall length of these samples were measured on the (b)(4) founding the overall length (124-125") within specification.Also the resistance wire was measure on the (b)(4) and the resistance values were found within specification (12.80 - 14.30 ohms).

• Brand Name: HUDSON CIRCUIT, HTD DUAL LIMB WITH WATER TRAPS
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton ; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas ; MX ; 9194334965
• MDR Report Key: 3975018
• MDR Text Key: 4888248
• Report Number: 3004365956-2014-00224
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• 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
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 780-36
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2014
• Initial Date FDA Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death