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 12/18/2021 |
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 nurse reported that a dialyzer blood leak occurred during a hemodialysis (hd) treatment.The blood leak was inside the arterial head of the dialyzer.The blood leak occurred when the hd treatment was started.The blood leak was noted as being an internal blood leak.The leak was visually observed.There was no observed damage to the dialyzer.Blood test strips were not used.The machine, a fresenius 4008s clasica, did not alarm with a blood leak alarm.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.The treatment was completed with a different machine and new supplies.The complaint device was reported to be discarded and will not be returned to the manufacturer for evaluation.
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Manufacturer Narrative
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Plant investigation: the complaint 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.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 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 nurse reported that a dialyzer blood leak occurred during a hemodialysis (hd) treatment.The blood leak was inside the arterial head of the dialyzer.The blood leak occurred when the hd treatment was started.The blood leak was noted as being an internal blood leak.The leak was visually observed.There was no observed damage to the dialyzer.Blood test strips were not used.The machine, a fresenius 4008s clasica, did not alarm with a blood leak alarm.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.The treatment was completed with a different machine and new supplies.The complaint device was reported to be discarded and will not be returned to the manufacturer for evaluation.
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Search Alerts/Recalls
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