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 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 08/12/2020 |
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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It was reported that a combi set blood leak occurred one hour into a patient's hemodialysis (hd) treatment.The blood leak was reportedly coming from the "t" connection on the bloodline, where the heparin tubing connects.There were no visible defects identified near the location of the leak.The combi set was reportedly inspected for defects prior to use, and nothing was found.There were no leaks noted during the priming of the lines, and it was unknown if there were any changes to the patient's blood flow rate during the treatment.The machine, a fresenius 4008s, did not alarm.The patient was also using a fresenius optiflux dialyzer.It was reportedly unknown if the patient's blood was returned.After the blood leak was identified, the treatment was halted.The patient completed their treatment after being re-setup with new supplies on a different machine.The patient's estimated blood loss (ebl) was approximately 50 ml.It was confirmed that there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The combi set was not available to be returned for a manufacturer evaluation as it was reportedly discarded.
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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.However, a photograph of the combi set connected to the machine was provided by the customer.Evidence of a blood leak was apparent in the provided photograph.The photograph shows blood leaking from the ¿t¿ connection on the bloodline, where the heparin line connects.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.The reported event was confirmed based on the provided photograph.
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