OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 0500316E |
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 10/12/2022 |
Event Type
malfunction
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Event Description
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A clinic manager reported that during a hemodialysis (hd) treatment a blood leak occurred.In a follow up, the manager clarified that the blood leak occurred as soon at blood hit the dialyzer after starting the hd treatment.The blood leak was described as being an internal blood leak.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.Fresenius bloodlines were used.The patient¿s estimated blood loss (ebl) was 100 ml.There was no patient injury, adverse events or medical intervention required as a result of this event.There was no visible damage to the dialyzer.The treatment was completed the same day with new supplies on the same machine.The device is available to be returned to the manufacturer for evaluation.
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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 clinic manager reported that during a hemodialysis (hd) treatment a blood leak occurred.In a follow up, the manager clarified that the blood leak occurred as soon at blood hit the dialyzer after starting the hd treatment.The blood leak was described as being an internal blood leak.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.Fresenius bloodlines were used.The patient¿s estimated blood loss (ebl) was 100 ml.There was no patient injury, adverse events or medical intervention required as a result of this event.There was no visible damage to the dialyzer.The treatment was completed the same day with new supplies on the same machine.The device is available to be returned to the manufacturer for evaluation.
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Manufacturer Narrative
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Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During gross visual examination, a looped fiber was observed at approximately 170° with the ports at 0° on the cavity id end.There was no other damage or irregularities noted on the returned sample.A review of the production record was performed.The production record review showed there was one unrelated approved temporary dn in the production of this lot.There was no indication of product non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to the complaint.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.The investigation into the complaint was able to confirm the reported event.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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