MAUDE Adverse Event Report: PNEUMOSTAT CHEST VALVE; BOTTLE, COLLECTION, VACUUM

Model Number 16100 - PNEUMOSTAT 10-PACK

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

It was reported that a patient went home with a pneumostat and came back to hospital with a pneumothorax.

Manufacturer Narrative

Based on the details of the complaint the patient was sent home with a pneumostat chest drain and returned to the hospital with a pneumothorax.As the patient was released to home with a pneumostat chest drain it is difficult to understand how the clinician can monitor the chest drain for proper operation as indicated within the instructions for use.The precautions section of the ifu states the following "patient tube connection, air leak well, and needleless luer-lock port should be checked regularly to confirm proper operation".Multiple questions were asked in an attempt to obtain more detailed information that would aid in the investigation.No response to our questions were received.Without the more detailed information, it is impossible to determine the root cause of the complaint or confirm the complaint.As the lot number of the pneumostat chest drain was not provided a review of the device history records could not be reviewed.Atrium medical corporation only releases product that has met all quality and performance requirements.Based on the details there is no claim of a product deficiency and there is no evidence to conclude that the pneumostat chest drain caused the pneumothorax.If the fluid output of the patient had exceeded or was about to be exceeded the collection volume of 30ml the patient should have gone back to the hospital so proper function of the drain could be assessed.There is also a possibility that the catheter or chest tube had been kinked during operation or that there was a leak where the catheter enters the patient.The instructions for use also specify that the drain must be kept in the upright position.It not know if this precaution was followed and could be a cause of a pneumothorax.Based on the details of the complaint atrium medical cannot confirm the complaint as there is no evidence that the pneumostat chest drainage system was the cause of the patient¿s condition.H3 other text: not available for return.

Event Description

N/a.

• Brand Name: PNEUMOSTAT CHEST VALVE
• Type of Device: BOTTLE, COLLECTION, VACUUM
• MDR Report Key: 10988973
• MDR Text Key: 220880105
• Report Number: 3011175548-2020-01429
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862161007
• UDI-Public: 00650862161007
• Combination Product (y/n): N
• PMA/PMN Number: K984496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16100 - PNEUMOSTAT 10-PACK
• Device Catalogue Number: 16100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention