ERIKA DE REYNOSA, S.A. DE C.V. COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Model Number 03-2622-3 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/02/2020 |
Event Type
malfunction
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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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Event Description
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A user facility reported that the fresenius combi set bloodlines were leaking blood from heparin line where line connects to the main bloodline.It was unknown how long into treatment the leak occurred.The patient¿s estimated blood loss (ebl) was 10 ml.There were no damages, loose connections, or any issues noted during priming.The heparin line of the bloodline detached from the main bloodline tubing during treatment.There were no injuries, adverse event, or medical intervention as a result of the reported event.The patient was able to complete treatment on the same machine with new supplies.The bloodlines are not available to be returned because they were discarded.Additional information was requested but reported to be unavailable.
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Search Alerts/Recalls
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