MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED VENTED AUTOFEED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

Model Number MR290V

Device Problems Crack (1135); Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr290v vented autofeed humidification chambers are currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in germany reported via a fisher & paykel healthcare (f&p) field representative, that two mr290v vented autofeed humidification chambers had a hole in the chamber base and were leaking water during patient use.There was no reported patient consequence.

Event Description

A healthcare facility in germany reported via a fisher & paykel healthcare (f&p) field representative, that two mr290v vented autofeed humidification chambers had a hole in the chamber dome and were leaking water during patient use.The customer reported usage of anaconda syringe which was connected to one of the inlet port.It was also reported that there was a spillage of medications which might be in contact with the mr290v.There was no reported patient consequence.

Manufacturer Narrative

(b)(4), method: the complaint mr290v vented autofeed humidification chambers were returned to fisher & paykel healthcare (f&p) in new zealand where they were visually inspected and analyzed.The customer reported usage of anaconda syringe which was connected to one of the inlet port.It was also reported that there was a spillage of medications which might be in contact with the mr290v.Results: visual inspection of the returned mr290v chambers revealed a large hole on both chamber dome.The location of holes were just right below one of the inlet port for both returned mr290v chambers.It was further noted that there was obvious sign of chemical attack (rough and bubbly dome finishing) around the hole.It is reasonably believed that the hole was caused by some unknown medications.Conclusion: based on the information provided by the customer and our investigation of the complaint device, the damage is most likely due to chemical attack.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.The subject chambers would have met the required specification prior to distribution.Our user instructions that accompany the mr290v vented autofeed humidification chamber states the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "use usp sterile water for inhalation or equivalent." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "use of the mr290 above the maximum operating pressure may lead to cracking, water leakage and, on rare occasions could lead to a loss of ventilation pressure.".

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14431656
• MDR Text Key: 295494648
• Report Number: 9611451-2022-00469
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

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: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: 2101922195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 08/31/2022
• 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
• Treatment: ANACONDA FILTER; ANAESTHESIA GAS; DRÄGER VN SERIES; DRÄGER VN SERIES; F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER; F&P RT265 INFANT EVAQUA2 BREATHING CIRCUIT; F&P RT265 INFANT EVAQUA2 BREATHING CIRCUIT