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 11/29/2019 |
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 clinical manager (cm) reported that blood was observed leaking externally from a fresenius bloodline approximately an hour and a half into a patient¿s hemodialysis (hd) treatment.Blood was seen dripping from the heparin line, where it connects to the heparin syringe that goes into the blood pump.The machine, a fresenius 2008t, did not alarm.There were no abnormalities noted at the source of the leak.There were no visible pinholes or tears, and no loose connections were found.The cm stated that tegaderm was applied to the tubing where the leak was coming from, and the patient¿s treatment was continued and completed.The estimated blood loss (ebl) was approximately 10 ml.Upon follow up, the cm confirmed that there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the event.The complaint device was discarded after the incident and was not available to be sent back for a physical evaluation.
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