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 12/01/2021 |
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 dialyzer blood leak was reported.A user facility clinical manager reported that a dialyzer blood leak occurred in the middle of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.Blood leak test strips were used and tested positive for the presence of blood.The leak was visually observed along the side of the dialyzer as well.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.The patient¿s estimated blood loss (ebl) was unknown.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on the same machine with new supplies and treatment completed successfully with new supplies.The complaint 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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Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.During the lot history review it was noted that there was one other complaint reported against the lot.The complaint addresses an internal blood leak (no sample).A review of the production record was performed.The production record review showed there was one approved temporary deviation notice (dn) 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.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 (vision systems) and (blood leak reduction) are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.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.
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Event Description
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A dialyzer blood leak was reported.A user facility clinical manager reported that a dialyzer blood leak occurred in the middle of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.Blood leak test strips were used and tested positive for the presence of blood.The leak was visually observed along the side of the dialyzer as well.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.The patient¿s estimated blood loss (ebl) was unknown.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on the same machine with new supplies and treatment completed successfully with new supplies.The complaint device was discarded and is not available to be returned to the manufacturer for evaluation.
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