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 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 03/01/2018 |
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 nurse reported that at the beginning of the patient¿s hemodialysis (hd) treatment, a blood leak occurred between the venous end of the combiset and the connection to the permacath.Per the clinic nurse, the leak was due to a loose connection and that the connection was not separated.The clinic nurse stated that there was a hemaclip (product information unknown) in place which is what kept the connection from separating.The connection was retightened and the patient successfully completed treatment on the same machine with the same supplies.There was no patient injury, adverse events, or medical intervention reported.The patient¿s estimated blood loss (ebl) was 300 ml.The permacath used by the patient is a non-fresenius device and manufacturer information was unknown.The combiset was discarded after treatment and is not available to be returned to the manufacturer for physical evaluation.
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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.Should additional relevant information become available, a supplemental report will be submitted.
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