Model Number IPN028446 |
Device Problem
Inability to Auto-Fill (1044)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that "the water seal chamber becomes overfilled with water after the pleura-vac has been set up.During set up in these instances, the water seal chamber has been set to the recommended 2 cm and the suction control chamber has been set to the recommended 20 cm of water.About an hour and a half after set up, it has been noticed that the water seal chamber is way over the 2 cm mark".At the time of this report, the customer has not returned our requests for additional information, specifically regarding patient details.If further information is received, the complaint file will be updated.
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Event Description
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It was reported that "the water seal chamber becomes overfilled with water after the pleura-vac has been set up.During set up in these instances, the water seal chamber has been set to the recommended 2 cm and the suction control chamber has been set to the recommended 20 cm of water.About an hour and a half after set up, it has been noticed that the water seal chamber is way over the 2 cm mark".
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Manufacturer Narrative
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(b)(4).Additional information received on 07 june 2023 states that the issue was resolved by using a new pler-evac from a different lot number.There was no patient harm or injury.Other remarks: n/a.Corrected data: n/a.
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Search Alerts/Recalls
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