Model Number OPTIFLUX 160NRE DIALYZER FINISHED ASSY. |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/08/2022 |
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 clinical manager reported that a dialyzer blood leak occurred less than five minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.The leak was not visually observed until the lines were pulled.It was then noticed at the header cap.The machine, a fresenius 2008t machine, alarmed appropriately with a ¿blood leak¿ alarm.Blood leak test strips were used and tested positive for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 280 ml.There was no patient injury reported or medical intervention required as a result of this event.The patient had hgb drawn and the sample was returned within range at 10.1 g/dl.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be unavailable for return to the manufacturer for evaluation.
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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 was one 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 for vision systems and 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 clinical manager reported that a dialyzer blood leak occurred less than five minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.The leak was not visually observed until the lines were pulled.It was then noticed at the header cap.The machine, a fresenius 2008t machine, alarmed appropriately with a ¿blood leak¿ alarm.Blood leak test strips were used and tested positive for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 280 ml.There was no patient injury reported or medical intervention required as a result of this event.The patient had hgb drawn and the sample was returned within range at 10.1 g/dl.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be unavailable for return to the manufacturer for evaluation.
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Search Alerts/Recalls
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