MAUDE Adverse Event Report: WATER STERILE F/INHALATION 2000ML 6/CS; INHALATION WATER SOLUTIONS

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

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Fever (1858); Tachycardia (2095)

Event Date 06/18/2021

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the water sterile f/inhalation 2000ml 6/cs experienced to have a white residue and caused their son to have a temperature and increased heart rate.

Manufacturer Narrative

Result of investigation: since the reported finding of the four bags with white residue is not related to the process controls in laboratorios pisa and since the root cause analysis could not identify any factor related to the reported complaint except a normal behavior from the pvc resin bag after extreme conditions which does not impact the quality or safety of the product, no corrective nor preventive actions can be implemented.

• Brand Name: WATER STERILE F/INHALATION 2000ML 6/CS
• Type of Device: INHALATION WATER SOLUTIONS
• MDR Report Key: 12163901
• MDR Text Key: 267659546
• Report Number: 3007502289-2021-00005
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10885403026607
• UDI-Public: (01)10885403026607(10)Q2101121
• Combination Product (y/n): N
• PMA/PMN Number: K090915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Date Manufacturer Received: 09/12/2021
• 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