ERIKA DE REYNOSA, S.A. DE C.V. COMBISET SMARTECH BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number 03-2722-9C |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 02/21/2024 |
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¿s biomedical technician (bmt) reported that a combi set bloodline leaked during a patient¿s hemodialysis (hd) treatment.Additional details were provided upon follow-up with the registered nurse (rn).She said that 2 hours and 50 minutes into the patient¿s treatment, the machine, a fresenius 2008t hemodialysis machine, alarmed for ¿air detected¿.A fresenius optiflux 180nre dialyzer was also in use.The external leak was visually observed from the bloodline tubing before the blood pump segment.There had been no changes or adjustments made to the patient¿s blood flow rate or disruption in pressure during the treatment.There was no visible damage to the bloodline.The patient¿s blood was not returned, and their estimated blood loss (ebl) was approximately 300 ml.There was no patient injury, adverse event or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint device is available to be returned to the manufacturer for evaluation.
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Event Description
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A user facility¿s biomedical technician (bmt) reported that a combi set bloodline leaked during a patient¿s hemodialysis (hd) treatment.Additional details were provided upon follow-up with the registered nurse (rn).She said that 2 hours and 50 minutes into the patient¿s treatment, the machine, a fresenius 2008t hemodialysis machine, alarmed for ¿air detected¿.A fresenius optiflux 180nre dialyzer was also in use.The external leak was visually observed from the bloodline tubing before the blood pump segment.There had been no changes or adjustments made to the patient¿s blood flow rate or disruption in pressure during the treatment.There was no visible damage to the bloodline.The patient¿s blood was not returned, and their estimated blood loss (ebl) was approximately 300 ml.There was no patient injury, adverse event or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint device is available to be returned to the manufacturer for evaluation.
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Manufacturer Narrative
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Additional information: d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During visual inspection it was found that the pump tubing had a cut causing a leak.After further inspection, no other problems were found.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.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.Upon completion of the evaluation, the reported event was confirmed.
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