MAUDE Adverse Event Report: MEDELA AG THOPAZ+ CHEST DRAINAGE SYS; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	079.1002
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	01/03/2026
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2026, it was reported to medela llc by medela ag that a thopaz plus was placed on a patient who later died.
Additional Manufacturer Narrative
The patient underwent a right lung wedge resection on (b)(6) 2025.During the surgery, a blake drain was placed in the pleural cavity and connected to a thopaz device.On (b)(6), the patient was accidentally dropped while in the bathroom, causing the thopaz device to fall to the floor.The plastic collection canister detached, and a large amount of air leaked out.The plastic canister and tubing were replaced and were found to function normally.Over the following days, the patient developed extensive subcutaneous emphysema, and on the morning of (b)(6) 2026, a tension pneumothorax developed, even though the drain was in place and suction was applied.A tension pneumothorax should not develop while a drain is in situ; therefore, a device malfunction is suspected.A sudden cardiac arrest occurred, leading to resuscitation attempts and ultimately death on (b)(6) 2026.
Additional Manufacturer Narrative
Medela ag has initiated the immediate return of the affected device for investigation to determine if any device malfunction or contribution of the affected device to the incident has occurred.The log file of the affected device was read out and analyzed by internal subject matter experts as well as an external medical expert in the field of cardiothoracic surgery.According to the data of the log file and the respective analysis it was concluded both by the internal experts as well as the external medical expert that the affected device performed as intended and no product malfunction was identifiable.An overall investigation including technical analysis of the affected device, review of risk management files, review of post market surveillance data and inclusion of external medical expert has been initiated.After the assessment of the incident with the external medical expert a set of additional questions was defined and shared with the hospital.These questions contain clarifications on the clinical background and information of the patient, details about chest drainage management and used protocols, detailed sequence of events of the incident as well as how the diagnosis of subcutaneous emphysema and tension pneumothorax was made and what treatment/actions were implemented.The answers on these questions are necessary for medela ag to perform a final assessment with the expertise of internal subject matter experts from risk management, clinical, design & development as well as the external medical expert.So far, even after a reminder, the hospital remains unresponsive to the follow-up questions.

• Brand Name: THOPAZ+ CHEST DRAINAGE SYS
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): MEDELA AG; 4b lattichstrasse; baar zug 6340 ; SZ 6340
• Manufacturer (Section G): MEDELA AG; 4b lattichstrasse; baar zug 6340 ; SZ 6340
• Manufacturer Contact: alea raber ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 24079523
• Report Number: 1419937-2026-00002
• Device Sequence Number: 12216517
• Product Code: OMP
• UDI-Device Identifier: 07612367043298
• UDI-Public: 07612367043298
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K141553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 079.1002
• Device Catalogue Number: 079.1002
• Device Lot Number: 0000644600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/14/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown