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Model Number ASU1201 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No sample was received for evaluation therefore we are unable to confirm the issue report.However, cardinal health has become aware of an issue in which the hydroline and pulse wave trumpet valves may not close properly, which could cause continuous suction.There is a remote possibility that inability to control suction during a procedure may result in loss of carbon dioxide in the abdomen, reduced visibility of the surgical site and potential injury to organs and body tissue.Cardinal health has issued a voluntary recall that was initiated on june 11th 2018.
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Event Description
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The valve system is not working properly.
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Manufacturer Narrative
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The actual complaint product was requested, but not received for evaluation.The device history record for the reported lot number has been reviewed for conformance to the cardinal health specifications.The product is tested 100% for leaks.Specifically the ¿aspiration button¿ is depressed, opened and closed several times during the test for leaks, and visual integrity appears to be in conformance.The product dhr conforms to cardinal health specifications.Testing had been performed prior to final packaging and sterilization and met all requirements.We are unable to confirm the issue report.However, cardinal health has become aware of an issue in which the hydroline and pulse wave trumpet valves may not close properly, which could cause continuous suction.There is a remote possibility that inability to control suction during a procedure may result in loss of carbon dioxide in the abdomen, reduced visibility of the surgical site and potential injury to organs and body tissue.Cardinal health has issued a voluntary recall that was initiated on june 11th 2018.
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Search Alerts/Recalls
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