Catalog Number 36-2438-0 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 11/11/2023 |
Event Type
malfunction
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Event Description
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Hold for kh 11/27.It was reported that a multifiltrate pro hd during a patient¿s continuous venovenous hemodiafiltration (cvvhdf) treatment.All pressures were in normal range, venous pressure 200mmhg, pre-filter 40mmhg, and access pressure 60mmhg.However, a blood leak occurred from the prefilter dome.The patient¿s blood was reinfused and the treatment was continued with a new kit.The patient experienced approximately 50 ml of blood loss.The sample was reported to not be available for evaluation.Additional information requested but has not been obtained.
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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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Manufacturer Narrative
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Additional information provided in b5 and d10.
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Event Description
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Upon follow up, it was confirmed that the treatment was restarted with a new kit on the same machine.After replacing the kit, the reported failure was not detected.The patient completed treatment after restarting.No repairs have been made to the machine.When blood loss occurred, the patient¿s vital signs were the same as before the treatment.There was no patient injury or medical intervention.No further details provided.
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Manufacturer Narrative
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Investigation: the complaint sample was not available for evaluation.Product batch production record controls resulted with conformity.Nonconformity was not observed during manufacturing process.There is no other complaint reported during complaint history review.The reported event is adequately documented in the instructions for use and/or the label.There is no indication that the reported failure relates to falsification.The retained samples were checked for defect, assembly failure, and leakage test which resulted in conformity.The reported event was not confirmed.
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Event Description
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Upon follow up, it was confirmed that the treatment was restarted with a new kit on the same machine.After replacing the kit, the reported failure was not detected.The patient completed treatment after restarting.No repairs have been made to the machine.When blood loss occurred, the patient¿s vital signs were the same as before the treatment.There was no patient injury or medical intervention.No further details provided.
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Search Alerts/Recalls
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