MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT BREATHING CIRCUIT; BTT

Model Number RT202

Device Problems Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); Pneumothorax (2012); Obstruction/Occlusion (2422)

Event Type  Death  

Event Description

A hospital in (b)(6) reported that a patient using an rt202 adult breathing circuit developed tension pneumothorax during suctioning and died after hospital staff had not deflated the cuff on a trache adaptor, thus blocking the patient's airway.

Manufacturer Narrative

(b)(4).No devices were returned to fisher & paykel healthcare (fph) in (b)(6) for evaluation.Samples of the equipment used in the incident were requested but have not been provided.The following information was provided by the hospital: - a tracheostomy patient was on an mr850 setup via a non-fph trache adaptor with the cuff inflated.- a closed suction catheter was connected to the trache adaptor via a t-piece connection - flow to patient was set at 60 lpm - a respiratory therapist (name not provided) responsible for the set-up had made a mistake in not deflating the cuff when using the setup described above the time and date of the incident was not provided by the hospital.Based on the description of events provided by the hospital, we can conclude that the patient was unable to expire the ventilatory gases as their airway was effectively blocked by the trache adaptor cuff.Flow would have entered the patient's lungs via the trache interface but would not have been able to escape due to the inflated cuff.There was no defect reported with the rt202 circuit, rather the problem was caused by inappropriate use of the non-fph trache adaptor with the suction catheter.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.The rt manager has acknowledged that (b)(6) hospital-(b)(6) rt staff knows that fisher & paykel healthcare does not advocate a closed suction catheter in-line with a trache adaptor and that the cuff should have been deflated.At the request of the rt manager a fisher & paykel healthcare field representative has met with hospital staff to offer further guidance on the correct setup for trache patients.

• Brand Name: ADULT BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9194534000
• MDR Report Key: 4886056
• MDR Text Key: 16456661
• Report Number: 9611451-2015-00298
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RT202
• Device Catalogue Number: RT202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: FISHER & PAYKEL MR850 HUMIDIFIER
• Patient Outcome(s): Death