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

Model Number	16100 - PNEUMOSTAT 10-PACK
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
It was reported that a patient went home with a pneumostat and came back to hospital with a pneumothorax.
Additional 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 or Problem Description
N/a.

• Brand Name: PNEUMOSTAT CHEST VALVE
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• MDR Report Key: 10988973
• Report Number: 3011175548-2020-01429
• Device Sequence Number: 869341
• Product Code: KDQ
• UDI-Device Identifier: 00650862161007
• UDI-Public: 00650862161007
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K984496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 16100 - PNEUMOSTAT 10-PACK
• Device Catalogue Number: 16100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention