Model Number IPN028484 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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In the emergency department and the pulmonology plant of the (b)(6) hospital it has been detected 6 times on 6 different patients since (b)(6) 2021 that the connection of the tube with the pleur-evac rubber is not watertight leading to the leaks in the chamber and event exit of pleural fluid trough the connection.This has generated errors in the diagnosis of the evolution of the patient's pulmonary pathology (detecting a non-real-leak) and causing late withdrawal of the thoracic tube, increasing the days of hospitalization, in addition to a possible risk of infection since not being properly sealed is a gateway to microorganisms.
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Manufacturer Narrative
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(b)(4).The device history record of batch number 74c2100034 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.Manufacture date: (b)(6) 2021.Expiration date:2024-02-28 two representative samples of catalog number s-1100-08lf (pe sahara dry suct/dry seal lf 6/cs) lot 74c2100034 was received for analysis.Samples were received in they original packaging sealed.The ats connector (p/n 152753) were reviewed after functional test and no issues were observed.Two representative samples of catalog number s-1100-08lf (pe sahara dry suct/dry seal lf 6/cs) lot 74c2100034 was received for analysis.Samples were received in they original packaging sealed.The ats connector (p/n 152753) were reviewed after functional test and no issues were observed.Customer complaint cannot be confirmed.No leaks were observed on ats connector (p/n 152753) on representative sample received.
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Event Description
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In the emergency department and the pulmonology plant of the san pedro hospital it has been detected 6 times on 6 different patients since (b)(6) 2021 that the connection of the tube with the pleur-evac rubber is not watertight leading to the leaks in the chamber and event exit of pleural fluid trough the connection.This has generated errors in the diagnosis of the evolution of the patient's pulmonary pathology (detecting a non-real-leak) and causing late withdrawal of the thoracic tube, increasing the days of hospitalization, in addition to a possible risk of infection since not being properly sealed is a gateway to microorganisms.
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Search Alerts/Recalls
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