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
Report received stated that the patient had a pneumostat, with leur lock adapter, attached to a catheter-based chest tube.Patient was at home and noticed fluid leaking between the blue plastic top and the body of the collection chamber.Collection chamber was not full, but at-home care is emptying the chamber out multiple times throughout the a day because of patient experiencing a large quantity of drainage.
Additional Manufacturer Narrative
Additional information: a.2, a.3 and a.4.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Correction section d.6 - no implant date this device is not an implantable device.The pneumostat drain was returned and still full of drainage.The device was disinfected and then inspected for any cracks or damage.No damage was noted.The pneumostat was then filled with water to the 30ml line.The drain did not leak while being held in the required upright position.The pneumostat was then placed on its side and it began to leak through the relief valve as expected.Once the drain was returned to the upright position the leakage stopped.It appears that the drain was not being used properly to prevent leakage.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.A full review of the device history records was conducted.The review indicates that this lot of pneumostats met all quality and performance criteria.There were no non-conformances related to the complaint.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 most likely the drain was leaking because it was not being kept in the upright position as required per the instructions for use.

• Brand Name: PNEUMOSTAT
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8757535
• Report Number: 3011175548-2019-00737
• Device Sequence Number: 1489527
• 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
• Device Implanted Year: 2019
• 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 Expiration Date: 01/04/2022
• Device Model Number: 16100
• Device Catalogue Number: 16100
• Device Lot Number: 441183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/09/2019; 08/15/2019
• Initial Report FDA Received Date: 07/03/2019
• 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