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 12/09/2021 |
Event Type
malfunction
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Event Description
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A user facility reported a dialyzer blood leak occurred four minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.No blood was observed within the dialysate.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was approximately 300 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient treatment was not restarted and the patient discontinued treatment on the day of the event.The patient returned the following day and completed treatment without issue.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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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 reported a dialyzer blood leak occurred four minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.No blood was observed within the dialysate.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was approximately 300 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient treatment was not restarted and the patient discontinued treatment on the day of the event.The patient returned the following day and completed treatment without issue.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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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 reported a dialyzer blood leak occurred four minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.No blood was observed within the dialysate.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was approximately 300 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient treatment was not restarted and the patient discontinued treatment on the day of the event.The patient returned the following day and completed treatment without issue.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: h6 component code.
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Manufacturer Narrative
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Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During the visual examination of the sample, a delamination was observed on the cavity id end of the dialyzer extending from approximately 310° to 80°, with the dialysate ports situated at 0°.The pu was noted as being low.No other damage or irregularities were noted on the returned sample.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.During the lot history review it was noted that there were no other complaints of any kind reported against the lot.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.The investigation into the complaint was able to confirm the reported event.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 2018-0171 (vision systems) and 2018-0161 (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 user facility reported a dialyzer blood leak occurred four minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.No blood was observed within the dialysate.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was approximately 300 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient treatment was not restarted and the patient discontinued treatment on the day of the event.The patient returned the following day and completed treatment without issue.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
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Search Alerts/Recalls
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