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 05/04/2022 |
Event Type
malfunction
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Event Description
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A materials manager reported that a dialyzer blood leak occurred during a hemodialysis (hd) treatment.In a follow up with a clinic manager, it was clarified that the blood leak occurred at one hour and three minutes into the hd treatment.The blood leak was described as being an internal blood leak that was visually seen at the hansen¿s connector.Blood tests strips were used and tested positive for the presence of blood.The machine was a fresenius 2008t machine.The machine did not alarm.The machine was removed from the floor and the treatment was completed with another machine and new supplies.There was no damage noted on the dialyzer prior to use.The patient¿s estimated blood loss (ebl) was greater than 100 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The treatment was interrupted but the patient was able to complete treatment without any further events.The device was discarded and is not 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 materials manager reported that a dialyzer blood leak occurred during a hemodialysis (hd) treatment.In a follow up with a clinic manager, it was clarified that the blood leak occurred at one hour and three minutes into the hd treatment.The blood leak was described as being an internal blood leak that was visually seen at the hansen¿s connector.Blood tests strips were used and tested positive for the presence of blood.The machine was a fresenius 2008t machine.The machine did not alarm.The machine was removed from the floor and the treatment was completed with another machine and new supplies.There was no damage noted on the dialyzer prior to use.The patient¿s estimated blood loss (ebl) was greater than 100 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The treatment was interrupted but the patient was able to complete treatment without any further events.The device was discarded and is not available to be returned to the manufacturer for evaluation.The machine is currently still being evaluated.
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Manufacturer Narrative
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Plant investigation: a sample has not been provided for evaluation.The report could not be confirmed as a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.A review of the production record was performed.The production record review showed there was one approved temporary deviation notice in the production of this lot.It is unrelated to the reported complaint event.There was no indication of product non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformance's, 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.There is no recall associated with this complaint.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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