OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 0500316E |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 12/22/2023 |
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 registered nurse (rn) reported that an internal dialyzer blood leak occurred approximately ninety minutes into a patient¿s hemodialysis (hd) treatment.The blood leak was not visually observed.The machine, a fresenius 2008t machine, alarmed twice with a minor blood leak alarm.Blood test strips were used at the arterial hansen and at the drain, and they both tested positive for blood.No physical damage was noticed on the dialyzer.Following the event, the treatment was paused.The patient¿s blood was not returned; estimated blood loss (ebl) was 300 ml.The rn 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 their treatment after being re-setup with new supplies on a different machine.The dialyzer was confirmed to be available 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 returned dialyzer.Blood was noted throughout the device.No damage or irregularities were identified on the returned sample.A laboratory bubble point leak test was performed on the dialyzer.No leak was detected.The dialyzer was then subjected to destructive disassembly for further visual examination.No damage or irregularities were found.Once dialyzer product is exposed to a post-production environment, such as clinic use, it is no longer of an original state as seen in quality testing for the release of product; as a result, laboratory testing may be inconclusive regarding the failure originally observed by the complainant facility.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There were two unrelated approved temporary deviation notices (dns) in the production of this 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.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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Event Description
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A user facility registered nurse (rn) reported that an internal dialyzer blood leak occurred approximately ninety minutes into a patient¿s hemodialysis (hd) treatment.The blood leak was not visually observed.The machine, a fresenius 2008t machine, alarmed twice with a minor blood leak alarm.Blood test strips were used at the arterial hansen and at the drain, and they both tested positive for blood.No physical damage was noticed on the dialyzer.Following the event, the treatment was paused.The patient¿s blood was not returned; estimated blood loss (ebl) was 300 ml.The rn 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 their treatment after being re-setup with new supplies on a different machine.The dialyzer was confirmed to be available for manufacturer evaluation.
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Search Alerts/Recalls
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