ERIKA DE REYNOSA, S.A. DE C.V. COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog 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 08/06/2019 |
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 biomedical technician (biomed) reported that the combi set bloodline¿s heparin line became loose during a patient treatment.The patient experienced blood loss.The fresenius 2008t machine did not sound an alarm.The patient¿s treatment was stopped and restarted with new supplies.Additional information was 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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