MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION PNEUMOSTAT

Model Number	16100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Event or Problem Description
The pneumostat drain leaked through the air leak monitor when in a position other than upright.Patient draining more than 30 ml per day.Patient was switched to an express mini without any issue and patient discharged the next day.
Additional Manufacturer Narrative
The returned device was opened and was noted that the device was still full of bodily fluids.The device was emptied and disinfected.The device was filled with water to the 30ml fill line and the device was held in the upright position as required by the instructions for use (ifu).The device was then placed with the face side down on the table.The device leaked as expected.The umbrella check valve was performing properly and is designed to leak and prevent air or fluid from going out the top of the pnuemostat back into the chest cavity.The fluid was leaking through the valve as it was not positioned in the upright position as required by the ifu and because the drain was collecting over 30ml of fluid a day.A device history record review was performed and the product was found to have met all specification.Clinical evaluation: the pneumostat drain is intended to evacuate air from the chest cavity and helps patients become ambulatory providing them with a dry seal and air leak monitor.If the collection chamber of the drain becomes full it must be replaced or it will leak body fluids creating a risk for blood borne pathogens.In order to prevent other fluid leaks it is important to maintain the drain in an upright position.A drain that leaks as a result of positioning would not affect the function of the drain.The ifu warns that this device is not to be used for fluid collection and that the chest drain valve must be kept in its upright position.

• Brand Name: PNEUMOSTAT
• Common Device Name: PNEUMOSTAT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• MDR Report Key: 6575471
• Report Number: 1219977-2017-00071
• Device Sequence Number: 133746
• Product Code: KDQ
• UDI-Device Identifier: 00650862161007
• UDI-Public: 00650862161007
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K984496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

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
• Operator of Device: Nurse
• Device Expiration Date: 01/31/2020
• Device Model Number: 16100
• Device Catalogue Number: 16100
• Device Lot Number: 220903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 70