ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Model 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 01/07/2021 |
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 technical services supervisor reported that a blood leak occurred at a user facility with a combiset during a patient¿s hemodialysis (hd) treatment on a fresenius 2008t machine.The blood leak was visually observed dripping from the heparin line by a patient care technician (pct) during a line check.When the pct attempted to address the leak, the heparin line popped off and blood squirted from the combiset.At that point, treatment was stopped and the patient¿s blood was rinsed back.The patient¿s estimated blood loss (ebl) was approximately 15 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient successfully completed treatment on the same machine with the new supplies.There was no damage seen on the combiset.The complaint device was discarded and is not available to be returned to the manufacturer for physical evaluation.
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