OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 0500318E |
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 10/03/2022 |
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 registered nurse (rn) reported that during a hemodialysis (hd) treatment there was a blood leak in the dialyzer.In a follow up, the rn clarified that the blood leak occurred within 30 seconds 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 not used due to visually seeing the leak in the effluent.Fresenius bloodlines were used.The patient¿s estimated blood loss (ebl) was 100ml to 250 ml.There was no patient injury 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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Event Description
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A registered nurse (rn) reported that during a hemodialysis (hd) treatment there was a biood leak in the dialyzer.In a follow up, the rn clarified that the blood leak occurred within 30 seconds 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 not used due to visually seeing the leak in the effluent.Fresenius bloodlines were used.The patient¿s estimated blood loss (ebl) was 100ml to 250 ml.There was no patient injury 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: a sample has not been provided for evaluation.The third party carrier's website was reviewed and it was verified that the fmcna-provided shipping materials were sent to the customer and were subsequently received.In the event a sample is returned for evaluation, the complaint file will be updated.The report could not be confirmed as a definitive conclusion regarding the complaint incident cannot be reached based on the information provided.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-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.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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