MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ STERILE WATER FOR INHALATION, USP 2000 ML; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number WATER STERILE F/INHALATION 2000ML 6/CS

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/29/2023

Event Type  malfunction  

Event Description

It was reported to vyaire medical that there was residue found or left in the 2d0737 - water sterile f/inhalation 2000ml 6/cs water chamber during patient use.It was also mentioned that the residue was found to range anywhere from 6¿28 days of use with the water chamber.The patients all remained stable with no adverse effects.

Manufacturer Narrative

H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Also, the issue happened with six patients.Please see com-(b)(4).Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.

Manufacturer Narrative

Additional information: g3, g6, h2, h3, h6 and h10 due to the unavailability of photographs and samples available for evaluation, it is not possible to determine the root cause of the event.The results of the physicochemical and microbiological laboratory tests comply with the specifications, as well as the results of product sterility.In addition, rejections and/or defectives such as "foreign particles in solution, turbid solution, foreign particles between bags or embedded" were segregated in a timely manner during the manufacturing process.It should be noted that localized defects other than the type of characteristic reported in this complaint were promptly segregated during the manufacturing process.Test results comply with validated parameters and product specifications.

• Brand Name: AIRLIFE¿ STERILE WATER FOR INHALATION, USP 2000 ML
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): LABORATORIOS PISA; s.a. de c.v. carretera san isi; dro mazatepec # 7000 tlajomulc; jalisco 45645 ; MX 45645
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18062235
• MDR Text Key: 327257004
• Report Number: 3013421741-2023-00045
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10190752196438
• UDI-Public: (01)10190752196438(10)Q2305399
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WATER STERILE F/INHALATION 2000ML 6/CS
• Device Catalogue Number: 2D0737
• Device Lot Number: Q2305399
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• 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