MAUDE Adverse Event Report: MEDELA AG THOPAZ+ PUMP SALE; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 0791000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemothorax (1896)

Event Type  Injury  

Manufacturer Narrative

The report alleges that the thopaz devices did not record the accumulation of liquid in the pleural cavity; however, the devices are not designed and not able to detect such liquid accumulation.The devices were received on 05/24/2019 and analyzed in july 2019.All five (5) of the devices were tested on the end-test equipment according to service specifications.All five (5) of the devices passed the test protocol and operated as intended/designed.The log files were retrieved from the devices and analyzed.All of the log files contain several therapies (related to more than one patient) and the reported adverse events cannot be correlated to a specific therapy.Therefore, the data in the log files was analyzed in total and not individually by therapy.Sn (b)(4): the device was manufactured on 10/21/2016.The log file contained several errors, possibly related to the buzzer, but those errors do not appear after a certain time.Furthermore, there were alarms related to clogged tubing and high liquid flow.There were no leakage alarms.Based on the analysis of the devices and the information provided in the report by the doctor, medela has concluded that the devices functioned as intended.

Event Description

The doctor reported that, on specific dates which were not reported, following pulmonary resection of five separate patients, the patient was placed on a thopaz chest drainage device.He indicated that in all cases, there were no post-operative air leaks and the presence of low blood loss in the device's canister.He additionally indicated that in all cases, an important hemothorax occurred, which in some of the cases (the quantity is unknown) forced re-operation.He alleged that without apparent abnormal functioning, the device did not report the accumulation of blood in the pleural cavity.The lack of detail in the report by the doctor does not allow for identification of the respective incidents reported and correlation of them to the individual device and use case.The other four (4) devices are reported in medwatches 1419937-2019-00111, 1419937-2019-00112, 1419937-2019-00113 and 1419937-2019-00115.

• Brand Name: THOPAZ+ PUMP SALE
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar 6341, ; SZ
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar 6341, ; SZ
• Manufacturer Contact: jan kloiber ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 8956178
• MDR Text Key: 156923689
• Report Number: 1419937-2019-00114
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K141553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0791000
• Device Catalogue Number: 0791000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Date Manufacturer Received: 05/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other