Model Number CAR-505 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation of the involved cartridge confirmed the venous connector was broken.The lot was released for distribution having met all product design, quality and product released criteria.No defects were found during incoming inspection of this lot.Nxstage medical considers this report closed.No additional information will be provided.
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Event Description
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A report was received on march 6, 2017 regarding a critical care patient where the venous tip of the luer broke off in the patient¿s catheter.There was no reported adverse event and no report that medical intervention was required.
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Event Description
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Additional information was received on april 10, 2017.A (b)(6) male patient was receiving crrt on (b)(6) 2016 and when the nurse attempted to disconnect the venous line from the patient's access the venous port broke inside the patient's catheter.The patient's dialysis catheter was removed as the patient remained stable and was discharged.
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Search Alerts/Recalls
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