MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION PNEUMOSTAT; BOTTLE, COLLECTION, VACUUM

Model Number	16100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
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
Nurse practitioner states that the patient had a pneumostat, with luer lock adapter, attached to a catheter-based chest tube in the hospital and experienced fluid leaking between the blue plastic top and the body of the collection chamber.
Additional Manufacturer Narrative
The pneumostat drain in question was not returned and the lot number not provided.Based on the details of the complaint it appears as if the drain was not kept in the upright position.This complaint is part of an associated complaint from the same case whereas the drain had been returned.The returned complaint concluded that the drain was not being used properly to prevent leakage and that there was no issue with the returned pneumostat.The details of the complaint stated that the pneumostat had to be drained multiple times a day as the fluid was regularly exceeding the volume of the pneumostat.The pneumostat drain is a disposable, single patient use chest drain valve for thoracic drainage with 30 ml collection volume.It is indicated for the evacuation of air from the chest cavity and not for larger volumes of drainage.Based on the results of the investigation and the details provided, atrium medical corporation cannot conclude that the device was at fault.The results of the investigation concluded that the drain was leaking because it was not being kept in the upright position as required per the instructions for use.H3 other text : not returned.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: age, sex and weight.
Event or Problem Description
N/a.

• Brand Name: PNEUMOSTAT
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8753900
• Report Number: 3011175548-2019-00733
• Device Sequence Number: 19259446
• Product Code: KDQ
• UDI-Device Identifier: 00650862161007
• UDI-Public: 00650862161007
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2019

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
• Device Catalogue Number: 16100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/23/2019; 08/15/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/03/2019; 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 77