OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 0500318E |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 04/11/2024 |
Event Type
malfunction
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Event Description
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A user facility¿s registered nurse (rn) reported that a visible internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008t hemodialysis machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested negative for the presence of blood.There was no defect or damage noted on the dialyzer.Fresenius bloodlines were also in use.The patient¿s estimated blood loss (ebl) was approximately 300ml.There was no patient injury, adverse event or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was discarded.
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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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Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There were multiple approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.Continuous improvement is of the utmost importance to fresenius medical care as we strive to provide dialysis products of the highest quality to our patients.Reports of leaking product are investigated both individually as complaints, as well as via the nc/capa program, in order to assess and improve our products and processes.Capas 2018-0171 (vision systems) and 1141369 (blood leak reduction) are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.
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Event Description
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A user facility¿s registered nurse (rn) reported that a visible internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008t hemodialysis machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested negative for the presence of blood.There was no defect or damage noted on the dialyzer.Fresenius bloodlines were also in use.The patient¿s estimated blood loss (ebl) was approximately 300ml.There was no patient injury, adverse event or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was discarded.
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