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 10/15/2022 |
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 user facility patient care technician (pct) reported an internal dialyzer blood leak that occurred immediately at the start of a patient¿s hemodialysis (hd) treatment.The blood leak was confirmed to be visually observed in the dialysate compartment of the dialyzer.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.A blood leak test strip was not used.No visible damage was observed on the dialyzer.Fresenius bloodlines were also being utilized for the treatment.After the machine alarmed, the treatment was paused.The patient¿s blood was not returned; estimated blood loss (ebl) was less than 300 ml.The pct confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed treatment after being resetup with new supplies on a different machine.The complaint device was reportedly available to be returned for manufacturer evaluation.
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Event Description
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A user facility patient care technician (pct) reported an internal dialyzer blood leak that occurred immediately at the start of a patient¿s hemodialysis (hd) treatment.The blood leak was confirmed to be visually observed in the dialysate compartment of the dialyzer.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.A blood leak test strip was not used.No visible damage was observed on the dialyzer.Fresenius bloodlines were also being utilized for the treatment.After the machine alarmed, the treatment was paused.The patient¿s blood was not returned; estimated blood loss (ebl) was less than 300 ml.The pct confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed treatment after being resetup with new supplies on a different machine.The complaint device was reportedly available to be returned for manufacturer evaluation.
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Manufacturer Narrative
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Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The corporate provided blood port and adapter caps were attached to the dialyzer.The fibers were wet with evidence of blood exposure.During gross visual examination, a delamination was observed on the cavity id end of the dialyzer extending from approximately 85° to 290° with the dialysate ports situated at 0°.Further examination of the complaint device did not identify any other damage or irregularities.The sample was not subjected to a laboratory leak test as a delamination is known to affect the integrity of the dialyzer and cause a leak.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was then 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.The investigation into the complaint was able to confirm the reported event.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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