Catalog Number CV-12854 |
Device Problems
Obstruction of Flow (2423); Material Twisted/Bent (2981)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Insufficient Information (4580)
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Event Date 03/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported "an extension line twisted, and it's blocking the good flow of the medication when using the syringe there is suppression and doesn't deliver the medication as it should.The patient does not receive the medication as he should, causing an increase in blood pressure on the patient.The extension line is bent to try to remove the twisted part." additional information reports "during the incident the patient's blood pressure dropped because the device was no longer delivering the drug properly.The problem was solved by turning the line upside down to remove the twisted part." the patient's current status is unknown at this time.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.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.
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Event Description
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It was reported "an extension line twisted, and it's blocking the good flow of the medication when using the syringe there is suppression and doesn't deliver the medication as it should.The patient does not receive the medication as he should, causing an increase in blood pressure on the patient.The extension line is bent to try to remove the twisted part." additional information reports "during the incident the patient's blood pressure dropped because the device was no longer delivering the drug properly.The problem was solved by turning the line upside down to remove the twisted part." the patient's current status is unknown at this time.
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Search Alerts/Recalls
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