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 05/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Plant investigation: 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 user facility nurse manager reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood as the leak could be visually observed within the dialyzer.The nurse stated that the leak was internal.There was no defect or damage seen on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 150 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The nurse manager noted that saline was administered to replace the blood loss per standing order.The patient was then restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
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Manufacturer Narrative
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Correction: h10 (the manufacturer's investigation confirmed the customer's reported issue).
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Event Description
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A user facility nurse manager reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008k2 machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood as the leak could be visually observed within the dialyzer.The nurse stated that the leak was internal.There was no defect or damage seen on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 150 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The nurse manager noted that saline was administered to replace the blood loss per standing order.The patient was then restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be unavailable to be returned to the manufacturer for evaluation.
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Event Description
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A user facility nurse manager reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008k2 machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood as the leak could be visually observed within the dialyzer.The nurse stated that the leak was internal.There was no defect or damage seen on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 150 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The nurse manager noted that saline was administered to replace the blood loss per standing order.The patient was then restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
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Event Description
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A user facility nurse manager reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008k2 machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood as the leak could be visually observed within the dialyzer.The nurse stated that the leak was internal.There was no defect or damage seen on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 150 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The nurse manager noted that saline was administered to replace the blood loss per standing order.The patient was then restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be unavailable 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.However there were seven photos provided by the customer.The six other photos show different angles of the same dialyzer where there appears to be blood on the outside of the fibers, within the dialyzer; however, a cause of the leak was not visible in the provided photographs.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.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.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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Manufacturer Narrative
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Correction: g3.The initial submission of this mdr incorrectly indicates that the event was reported to the manufacturer on 05/12/2022.The correct date is 05/11/2022.Additional information: b5 (confirmation that the complaint sample is unavailable), d9, g1, h3.
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Event Description
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A user facility nurse manager reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008k2 machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood as the leak could be visually observed within the dialyzer.The nurse stated that the leak was internal.There was no defect or damage seen on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 150 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The nurse manager noted that saline was administered to replace the blood loss per standing order.The patient was then restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be unavailable to be returned to the manufacturer for evaluation.
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Search Alerts/Recalls
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