Catalog Number CS-15402-E |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010); Pericardial Effusion (3271)
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Event Date 04/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The patient's condition is reported as fine.However, the patient is still in the hospital because of prematurity.Additional information: the x ray performed after the surgery did not show a migration of the catheter.The cardiorespiratory insufficiency and right pleural effusion and pericardial effusion has no link with the condition of the baby who was in the resuscitation room for a ileo-colic resection that finished a stoma.Intervention: the incident lead to a treatment with norepinephrine (up to 0.48 g / kg /min) and dobutamine (at a maximum dose of 0.9 g / kg / min).The catheter was removed and placement of a new catheter in the left clavicle.
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Event Description
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It was reported that: in the resuscitation room, concerning a premature new-born baby who had a surgery on (b)(6) 2018 for ileo-colic resection with insertion of a stoma.A pediatric cvc is inserted in the supraclavicular way during the intervention.The newborn is then sent to intensive care.On (b)(6) 2018, discovery of a "perfusothorax" (migration of the catheter) with cardiorespiratory insufficiency.With also a right pleural effusion and circumferential pericardial effusion.Clinical consequences: hypotension and anuria requiring the increase of noradrenaline (up to 0.48 g / kg / min) and introduction of dobutamine (at the maximum dose of 0.9 g / kg / min).Life-threatening.Catheter was removed and replaced by a left supraclavicular catheter.
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Event Description
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It was reported that: in the resuscitation room, concerning a premature new-born baby who had a surgery on (b)(6) 2018 for ileo-colic resection with insertion of a stoma.A pediatric cvc is inserted in the supraclavicular way during the intervention.The newborn is then sent to intensive care.On the (b)(6) 2018, discovery of a "perfusothorax" (migration of the catheter) with cardiorespiratory insufficiency.With also a right pleural effusion and circumferential pericardial effusion.Clinical consequences: hypotension and anuria requiring the increase of noradrenaline (up to 0.48 g / kg / min) and introduction of dobutamine (at the maximum dose of 0.9 g / kg / min).Life-threatening.Catheter was removed and replaced by a left supraclavicular catheter.
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Manufacturer Narrative
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Qn#(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.
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Search Alerts/Recalls
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