MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH; CIRCUIT, BREATHING (W CONNECTO

Catalog Number 1607

Device Problem Decoupling (1145)

Patient Problems Death (1802); Respiratory Failure (2484)

Event Date 07/29/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).It was reported the patient's cause of death was possibly respiratory failure, but there is no documentation related to official cause of death.The user facility reported they did not know why the ventilator tubing disconnected, but thought the connection was loose.The user facility also noted the ventilators are loud and the alarms can be difficult to hear.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Customer reported an incident surrounding a breathing hose coming off a ventilator.The patient was on a portable ventilator for 13 days with high peak pressures.When the provider went into the room, the tubing was disconnected from the ventilator.The patient was on multiple drips and couldn't breathe on his own.Patient was reported to be under a 'do not resuscitate' (dnr) order and therefore no resuscitation attempt was made.The patient died on (b)(6) 2020.The customer reported the inspiratory side hose is loose and prone to come off.Per customer, the high pressure ventilation many patients require can lead to 'pop-offs' of the ventilator tubing from the ventilator equipment.

• Brand Name: HUDSON VENTILATOR TUBING SET,LONG LENGTH
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 10441859
• MDR Text Key: 203996522
• Report Number: 3004365956-2020-00155
• Device Sequence Number: 1
• Product Code: CAI
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1607
• Device Lot Number: 74D2000023
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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
• Treatment: PATIENT ON MULTIPLE DRIPS
• Patient Outcome(s): Death