MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT; BZE

Model Number RT235

Device Problem Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6), reported to a fisher & paykel healthcare (fph) representative that an rt235 infant dual heated evaqua breathing circuit was over heating.The hospital further reported that a patient received a second degree burn on the leg below the knee.No further patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint rt235 infant dual heated evaqua breathing circuit was not returned to fisher & paykel healthcare.The hospital disposed of the circuit before we could request it for evaluation.Therefore, our investigation is based on the information provided by the hospital and our knowledge of the product.Results: the hospital reported that the rt235 circuit was used at flow rates between 1 and 2 lpm.Furthermore, it was reported that the circuit was on top of exposed skin and underneath bed covers.Fph representatives were also informed that the hospital staff were wrapping breathing circuits in bed sheets to insulate the patient from the circuits.A performance test of the mr850 respiratory humidifier included in the set up at the time of the reported incident showed that it was operating normally.A lot check could not be carried out as the lot information was not provided.Conclusion: the rt235 infant dual heated evaqua breathing circuit is designed to be used at flow rates greater than 4 lpm.The hospital staff were using the rt235 circuit outside the flow rates specified in the rt235 user instructions.In addition, the user instructions also state the following: "avoid prolonged contact with patient's skin" "do not cover the circuit with materials such as blankets, towels or bed linen." upon receiving the reported complaint, fph representatives visited the hospital and advised staff to follow the rt235 user instructions and to avoid wrapping any circuits with sheets.Fph representatives are planning additional training sessions with the hospital staff on the correct set up and use of the rt235 circuits.All rt235 breathing circuits are visually inspected and pressure tested for leaks before being released for distribution and any circuit that fails is discarded.In addition, tube weighing and bond strength tests are performed every 15 minutes; if this test detects a fault, the whole batch is placed on hold for further investigation.Without the return of the complaint device we are unable to confirm whether there was any fault with the rt235 circuit.

• Brand Name: INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT
• Type of Device: BZE
• 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: 3686044
• MDR Text Key: 4259961
• Report Number: 9611451-2014-00231
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT235
• Device Catalogue Number: RT235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 03/18/2014
• 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: FPH MR850 RESPIRATORY HUMDIFIER; DRAGER EVITA VENTILATOR