Model Number IPN030096 |
Device Problem
Expulsion (2933)
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Patient Problems
No Consequences Or Impact To Patient (2199); Blood Loss (2597)
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Event Date 09/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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The complaint is reported as, "involving (b)(6)-year-old patient in treatment for cardiac decompensation associated with cardio-renal syndrome (context : degeneration of a tavi (transcatheter aortic valve implantation) inserted in 2015.A dialysis catheter was inserted in the left jugular on (b)(6) 2020 to perform continuous hemofiltration that started on (b)(6) 2020 at 1 p.M.On (b)(6) 2020, at 7:30 p.M., during the patient's lateralization for nursing care, the catheter suddenly removed from his left jugular venous.Some blood spilled on the staff, on the bed and on the patient.The juncture hub remained in place.There was a minimal blood loss at the point of the puncture.Loss of blood in the circuit hemofiltration was approximately 200 ml.No other catheter was inserted." the patient's condition is reported as fine.It was reported the infectious risk for medical staff after bleeding is over.
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Manufacturer Narrative
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Qn# (b)(4).The customer returned one 2-lumen catheter and a representative catheter for evaluation.The actual juncture hub clamp and clamp catheter were not returned for evaluation.Visual examination of the returned samples did not reveal any defects or anomalies.Visual examination of the actual juncture hub clamp and clamp catheter could not be performed as they were not returned for evaluation.The outer diameter of the returned catheter body measured to be 4.68 mm which is within specifications of 4.62-4.72 mm per product drawing.Dimensional examination of the actual clamp catheter could not be performed as it was not returned for evaluation.The outer diameter of the representative catheter body measured to be 4.66 mm which is within specifications of 4.62-4.72 mm per product drawing.The inner diameter of the representative clamp catheter measured to be 4.06 mm which is within specifications of 3.9-4.5 mm per product drawing.To functionally test the device, the representative catheter clamp was attached to the actual and representative catheter bodies.The catheter bodies were then tugged in both directions while the clamp was held stationary.The clamp did not shift position on the catheter bodies and the catheters were not able to migrate.Functional examination of the actual juncture hub clamp and clamp catheter could not be performed as they were not returned for evaluation.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit instructs the user, "secure catheter to patient.Use triangular juncture hub with integral rotating suture wings as primary suture site." the customer report of a catheter migration could not be confirmed by complaint investigation of the returned sample.The actual and representative samples passed all relevant visual, dimensional, and functional testing.A device history record review was performed with no relevant findings.The probable root cause could not be determined based on the sample received and without the actual clamp catheter and juncture hub clamp to evaluate.Teleflex will continue to monitor and trend for complaints of this nature.
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Event Description
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The complaint is reported as: "involving 65-year-old patient in treatment for cardiac decompensation associated with cardio-renal syndrome (context : degeneration of a tavi (transcatheter aortic valve implantation) inserted in 2015.A dialysis catheter was inserted in the left jugular on (b)(6) to perform continuous hemofiltration that started on (b)(6) at 1 p.M.On (b)(6) at 7:30 p.M., during the patient's lateralization for nursing care, the catheter suddenly removed from his left jugular venous.Some blood spilled on the staff, on the bed and on the patient.The juncture hub remained in place.There was a minimal blood loss at the point of the puncture.Loss of blood in the circuit hemofiltration was approximately 200 ml.No other catheter was inserted." the patient's condition is reported as fine.It was reported the infectious risk for medical staff after bleeding is over.
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Search Alerts/Recalls
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