Model Number IPN038320 |
Device Problem
Contamination (1120)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/16/2019 |
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: "during ongoing cica, pressure increased in the venous line.The dialysis was stopped as cica was no longer possible.When disconnecting a tubing-like material (approx.10 cm length) was pulled out of the line running towards the patient of the dialysis catheter.The material does not seem like coagulum but rather like rubber; the foreign material is secured and can be examined." it was reported the customer did not see the problem with the catheter, but with the dialysis machine from fresenius.
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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.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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Event Description
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The complaint is reporeted as: "during ongoing cica, pressure increased in the venous line.The dialysis was stopped as cica was no longer possible.When disconnecting a tubing-like material (approx.10 cm length) was pulled out of the line running towards the patient of the dialysis catheter.The material does not seem like coagulum but rather like rubber; the foreign material is secured and can be examined." it was reported the customer did not see the problem with the catheter, but with the dialysis machine from fresenius.
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Search Alerts/Recalls
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