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

Model Number	16100
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/13/2018
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
It was reported the patient had intercostal tube damage from pneumothorax.The pneumostat was connected to the existing implantable cardioverter defibrillator (icd).Post attachment an external air leak was noticed and the pneumostat was disconnected.On examination a small crack on the inlet part was noticed.
Additional Manufacturer Narrative
The returned drain was received and inspected.Upon initial inspection the drain was remarkably clean with no bodily fluids within the drain or any of the connectors.The tube set returned with the drain was put in place and the vacuum applied.No leak in the drain was noticed.This was repeated with both tube sets that were provided.The vacuum applied was generated by using a 20cc syringe with 5cc of water within it.The barrel of the syringe was retracted pulling a vacuum.This was repeated multiple times so as to generate the strongest vacuum possible.The vacuum generated was strong enough to pull the syringe barrel down when the stopcock was opened.Upon the final vacuum no bubbles of air were seen coming into the syringe barrel that would signify a leak.The drain was then evaluated under the microscope at 20 x magnification to determine if there were any visible cracks or damage that would have caused the drain to leak.No damage was noticed.The one connector on the tube set that is blue had been compressed at some point causing material stress marks but no cracks were evident and there was no leaking.The compression marks are indicative of forcep clamps.Based on the investigation we cannot conclude that the pnuemostat drain is damaged or leaking.The returned drain performed as expected.The investigation could not duplicate the leak.The pneumostat chest valve is intended to evacuate air from the chest cavity.An air leak can occur in a chest drainage system for several reasons.An air leak would occur on the device side if there was a loose connection between the patient and the drain.A pleural leak would be a result of the thoracic catheter becoming dislodged, or pulled out of the chest wall insertion site.An leak can also occur if the device has been damaged or cracked.It is imperative that chest drainage systems and patient status be methodically assessed at frequent and regular intervals.The system must be checked for loose connections, tubing security and presence or absence of air leak.Other inspections include kinking of the tubing, dependent loops, closed clamps, color and character of the drainage, the rate of drainage, the water seal, bubbling (continuous or intermittent) and the negative pressure indicator.The instructions for use (ifu) states patient tube connection, air leak well, and needleless luer-lock port should be checked regularly to confirm proper operation.The ifu also states do not use if device or package is damaged.
Event or Problem Description
N/a.

• Brand Name: PNEUMOSTAT
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7862467
• Report Number: 3011175548-2018-00998
• Device Sequence Number: 16574078
• Product Code: KDQ
• UDI-Device Identifier: 00650862161007
• UDI-Public: 00650862161007
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 16100
• Device Catalogue Number: 16100
• Device Lot Number: 222780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Device Age: YR
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 46