ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number 03-2722-9 |
Device Problems
Air Leak (1008); Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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Event Description
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A user facility clinical education coordinator reported that a fresenius dialyzer and fresenius custom combiset combination had air in the line and subsequent clotting during a patient's hemodialysis (hd) treatment.Additional information has been requested, however, to date not provided.
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Manufacturer Narrative
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Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
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Search Alerts/Recalls
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