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 04/13/2017.The log file contained many clogged filter and clogged tube alarms.In later therapies, the log contained alarms related to high liquid flow.There was one leakage alarm.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.
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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, 1419937-2019-00114 and 1419937-2019-00115.
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