Catalog Number VASCULAR UNKNOWN |
Device Problem
Material Separation (1562)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/27/2020 |
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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The customer reports: the patient entered in the hospital because of a sceptic shock 4 days before the incident.On the 4th day of hospitalization, the catheter spontaneously separated from the rest of the device at level of the blue luer hub.This separation led to hypotension / failure of infusing amines.A new long central catheter had to be inserted.Clinical consequences: the patient's hypotension was fixed and no negative consequences for the patient.
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Manufacturer Narrative
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Qn#(b)(4).The actual device was not returned; however the customer provided one photo for evaluation.The photo displayed a 3-lumen cvc with an arrow pointing to the distal end of the juncture hub.An image showing a box clamp assembly with the sutures was also provided.Full visual inspection could not be performed as no sample was returned for analysis.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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The customer reports: the patient entered in the hospital because of a sceptic shock 4 days before the incident.On the 4th day of hospitalization, the catheter spontaneously separated from the rest of the device at level of the blue luer hub.This separation led to hypotension / failure of infusing amines.A new long central catheter had to be inserted.Clinical consequences: the patient's hypotension was fixed and no negative consequences for the patient.
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Search Alerts/Recalls
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