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 Problems
Fluid/Blood Leak (1250); Separation Problem (4043)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/09/2020 |
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 reported that the heparin line of the combi set bloodlines detached from the main bloodline tubing during treatment causing a blood leak.It was unknown how long into the patient¿s hemodialysis (hd) treatment the blood leak occurred.The patient¿s estimated blood loss (ebl) was approximately 50 ml.There were no damages, loose connections, or any issues noted during priming.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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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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