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

Model Number 900MR810

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint breathing circuit is currently en route to fisher & paykel healthcare (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that an 900mr810 reusable adult breathing circuit was torn and leaking.The circuit had been in use for two and a half months before the incident occurred.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint breathing circuit was received at fisher & paykel healthcare in (b)(4) for evaluation.Results: visual inspection revealed a 35mm tear in the tubing film where it joins the patient end over-moulded cuff.Conclusion: we were unable to determine what had caused the observed damage.The customer has confirmed that the subject breathing circuit passed the initial leak test and was in use for two and a half months before a leak was observed, which indicates that the circuit became damaged during use, possibly during the cleaning process.The 900mr810 breathing circuits are leak tested and visually inspected during production.Our user instructions that accompany the 900mr810 reusable breathing circuit contain the following warnings: clean circuit prior to use and after each patient use, using approved disinfection methods only.Use of unapproved cleaning methods may damage the circuit and reduce it useable life.Inspect circuit before re-use, do not use if the circuit shows sign of deterioration, such as cracks, tears or damage.Disconnect tube by handling end connectors only, do not pull or twist tubing, as this may cause damage.

Event Description

A healthcare facility in (b)(6) reported that an 900mr810 reusable adult breathing circuit was torn and leaking.The circuit had been in use for two and a half months before the incident occurred.There was no patient consequence.

• Brand Name: REUSABLE 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 ; 9494534000
• MDR Report Key: 4521814
• MDR Text Key: 22227574
• Report Number: 9611451-2015-00093
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900MR810
• Device Catalogue Number: 900MR810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2015
• 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