MAUDE Adverse Event Report: MEDELA AG THOPAZ+ DRAINAGE SYSTEM LOAN 1CT PT-A 19; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number	101029471
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The medela thopaz+ pump was removed from the patient due to an error message and was replaced with a competitor's pump.On 9/4/25 the thopaz+ was delivered to medela llc and was evaluated on (b)(6) 2025.The device was run for one hour and no error messages occurred.The log file showed recent errors but could not be reproduced.The device passed testing.
Event or Problem Description
On (b)(6) 2025, a facility contacted medela llc and alleged that while using a thopaz+ pump an internal error message occurred.It is undetermined the length of time the error message was on until discovered by the treating surgeon in the morning.The patient developed pneumothorax.

• Brand Name: THOPAZ+ DRAINAGE SYSTEM LOAN 1CT PT-A 19
• Common Device Name: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer Contact: tom cuzman ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 23014949
• Report Number: 1419937-2025-00025
• Device Sequence Number: 18535245
• Product Code: BTA
• UDI-Device Identifier: 07612367041027
• UDI-Public: 7612367041027
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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: 101029471
• Device Catalogue Number: 101029471
• Device Lot Number: 0000731758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• Distributor Facility Aware Date: 08/19/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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: Hospitalization
• Patient Sex: Unknown