MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEONATE DUAL HEAT; BREATHING CIRCUIT

Catalog Number 880-15KIT

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A device history record could not be conducted since the lot number was not provided.The device sample was received by the manufacturer but the investigation is incomplete at the time of this report.

Event Description

The customer alleges that the circuit was melted in two areas.The circuit was replaced.No patient injury or harm reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the translucent (expiratory) side of the limb displayed two areas that appear to be melted/damaged.The visual inspection also confirmed that the heated wires of the limb have not been misplaced, or "bunched" at any point in the circuit, which could cause temperatures high enough to melt the plastic tubing.The heated wires of the damaged/melted expiratory limb show no signs of damage or discoloration that might indicate the plastic insulation of the wires overheated.The damaged areas show melting taking place on top of the circuit pipe ridges which suggest the circuit limb might have come in contact with something hot from an external source instead of the internal heated wire.Based on the investigation performed, the reported complaint was confirmed.Although the complaint was confirmed, a root cause for the melted circuit could not be determined.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 was melted in two areas.The circuit was replaced.No patient injury or harm reported.

• Brand Name: HUDSON NEONATE DUAL HEAT
• Type of Device: BREATHING CIRCUIT
• 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: 5064437
• MDR Text Key: 25275180
• Report Number: 3004365956-2015-00278
• 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: company representative,health
• Reporter Occupation: Respiratory Therapist
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 880-15KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2015
• 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