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 Problems
Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/05/2022 |
Event Type
Injury
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Event Description
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It was reported a hemodialysis (hd) patient experienced an optiflux 180nre dialyzer blood leak during hd therapy on (b)(6) 2022.The reported blood leak occurred where the hollow fibers connect with the dialyzer cap.Subsequent attempts to obtain additional information (e.G., treatment record, discharge summary, hospital records) have thus far proven unsuccessful.It is unknown if the optiflux 180nre dialyzer was saved following the event, or whether other dialyzers from the same lot were utilized with other patients.
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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.Clinical investigation: a temporal relationship exists between hd therapy utilizing an optiflux 180nre dialyzer, and the serious adverse events of blood loss (volume not provided) and hospitalization, as the patient was actively undergoing hd therapy when the events occurred.During complaint intake, it was reported the blood leak could be visualized coming through ¿the cap where the fibers connect to the top.¿ the optiflux 180nre dialyzer instructions for use state, all connections must be secure prior to initiating hd therapy to prevent blood leaks¿ however overtightening can lead to cracks.While uncommon, blood leak events are a known potential complication of utilizing optiflux series dialyzers during hd therapy.Furthermore, it should be noted a hd system may not alarm in every blood loss situation.Based on the totality of the information available, the optiflux 180nre dialyzer cannot be excluded from having a probable causal role in the patient¿s blood loss and subsequent hospitalization.During intake, the report indicated a fresenius product(s) defect and/or malfunction occurred during treatment, which led to the patient¿s blood loss.If the optiflux 180nre dialyzer is returned, a manufacturer evaluation may disassociate the dialyzer from having caused the serious adverse events.However, without a product evaluation, discharge summary, and treatment records, this clinical investigation cannot disassociate the product from the serious adverse events.
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Manufacturer Narrative
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Correction: h10 clinical investigation clinical investigation: there is no evidence the patient was hospitalized following the blood leak, therefore negating the need for a clinical investigation.Therefore the clinical investigation will be closed.
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Event Description
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It was reported a hemodialysis (hd) patient experienced an optiflux 180nre dialyzer blood leak during hd therapy on (b)(6) 2022.The reported blood leak occurred where the hollow fibers connect with the dialyzer cap.Subsequent attempts to obtain additional information (e.G., treatment record, discharge summary, hospital records) have thus far proven unsuccessful.It is unknown if the optiflux 180nre dialyzer was saved following the event, or whether other dialyzers from the same lot were utilized with other patients.
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Event Description
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It was reported a hemodialysis (hd) patient experienced an optiflux 180nre dialyzer blood leak during hd therapy on (b)(6) 2022.The reported blood leak occurred where the hollow fibers connect with the dialyzer cap.The patient had forty minutes left to go and was actually rushed to local hospital.Subsequent attempts to obtain additional information (e.G., treatment record, discharge summary, hospital records) have thus far proven unsuccessful.It is unknown if the optiflux 180nre dialyzer was saved following the event, or whether other dialyzers from the same lot were utilized with other patients.
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Manufacturer Narrative
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Clinical investigation clinical investigation: a temporal relationship exists between hd therapy utilizing an optiflux 180nre dialyzer, and the serious adverse events of blood loss (volume not provided) and subsequent hospitalization, as the patient was actively undergoing treatment when the events occurred.Limited information precluded a more comprehensive investigation.During complaint intake, it was reported the blood leak could be visualized coming through ¿the cap where the fibers connect to the top.¿ the optiflux 180nre dialyzer instructions for use state, all connections must be secure prior to initiating hd therapy to prevent blood leaks.However overtightening can lead to cracks.While uncommon, blood leak events are a known potential complication of utilizing optiflux series dialyzers during hd therapy.Furthermore, it should be noted a hd system may not alarm in every blood loss situation.Based on the totality of the information available, the optiflux 180nre dialyzer cannot be excluded from having a probable causal role in the patient¿s blood loss.During intake, the report indicated a fresenius product(s) defect and/or malfunction occurred during treatment, which led to the patient¿s blood loss.If the optiflux 180nre dialyzer is returned, a manufacturer evaluation may disassociate the dialyzer from having caused the serious adverse events.However, without a product evaluation and treatment records, this clinical investigation cannot disassociate the product from the serious adverse events.
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Manufacturer Narrative
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Correction: b1, b2, h1, h6 health effect - clinical code section, h10 clinical investigation clinical investigation: a temporal relationship exists between hd therapy utilizing an optiflux 180nre dialyzer, and the serious adverse events of blood loss (volume not provided), as the patient was actively undergoing hd therapy when the events occurred.During complaint intake, it was reported the blood leak could be visualized coming through ¿the cap where the fibers connect to the top.¿ the optiflux 180nre dialyzer instructions for use state, all connections must be secure prior to initiating hd therapy to prevent blood leaks.However overtightening can lead to cracks.While uncommon, blood leak events are a known potential complication of utilizing optiflux series dialyzers during hd therapy.Furthermore, it should be noted a hd system may not alarm in every blood loss situation.Based on the totality of the information available, the optiflux 180nre dialyzer cannot be excluded from having a probable causal role in the patient¿s blood loss.During intake, the report indicated a fresenius product(s) defect and/or malfunction occurred during treatment, which led to the patient¿s blood loss.If the optiflux 180nre dialyzer is returned, a manufacturer evaluation may disassociate the dialyzer from having caused the serious adverse events.However, without a product evaluation and treatment records, this clinical investigation cannot disassociate the product from the serious adverse events.
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Event Description
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It was reported a hemodialysis (hd) patient experienced an optiflux 180nre dialyzer blood leak during hd therapy on (b)(6) 2022.The reported blood leak occurred where the hollow fibers connect with the dialyzer cap.Subsequent attempts to obtain additional information (e.G., treatment record, discharge summary, hospital records) have thus far proven unsuccessful.It is unknown if the optiflux 180nre dialyzer was saved following the event, or whether other dialyzers from the same lot were utilized with other patients.
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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.During the lot history review it was noted that there was one other complaint reported against the lot.The complaint is mentioned above and addresses an external prime leak (no sample).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.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.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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It was reported a hemodialysis (hd) patient experienced an optiflux 180nre dialyzer blood leak during hd therapy on (b)(4) 2022.The reported blood leak occurred where the hollow fibers connect with the dialyzer cap.The patient had forty minutes left to go and was actually rushed to local hospital.Sbsequent attempts to obtain additional information (e.G., treatment record, discharge summary, hospital records) have thus far proven unsuccessful.It is unknown if the optiflux 180nre dialyzer was saved following the event, or whether other dialyzers from the same lot were utilized with other patients.
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