OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 0500318N |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombocytopenia (4431)
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Event Date 01/01/2021 |
Event Type
Injury
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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.Clinical investigation: based on the available information, there is a temporal and a likely causal relationship between the fresenius optiflux f180nr dialyzer and the patient¿s thrombocytopenia characterized by a decline in platelet count post dialysis treatment.Although rare, thrombocytopenia reactions to the dialyzer may occur during hemodialysis.This is a known risk factor.In this instance, the patient had a normal platelet count at baseline and experienced a marked decline in platelet count following dialysis with a polysulfone membrane dialyzer which resolved after transfer to a cellulose triacetate membrane substitution.Despite the patient¿s reaction to the polysulfone membrane dialyzer resulting in thrombocytopenia, there is no evidence or allegation of a fresenius f180nr optiflux dialyzer malfunction or deficiency reported for this event.
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Event Description
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Fresenius was made aware of an article published in the july 2021 issue of the american journal of case reports which documents a dialyzer reaction.The journal article, ¿thrombocytopenia induced by polysulfone dialysis membranes¿, captured the dialyzer reaction experienced by a patient initiated on hemodialysis (hd).This patient presented to the hospital with weakness, melena, and fatigue and was admitted (unknown date) for recurrent gastrointestinal (gi) bleeding and acute kidney injury.The patient had a history of stage 5 chronic kidney disease.Upon admission to the hospital, the patient¿s hemoglobin was 4.9 g/dl.The patient received red blood cell transfusions (amount unknown) which increased their hemoglobin to a threshold of 7g/dl.One year prior to this hospitalization, the patient required a right hemicolectomy due to a cecal perforation caused during a colonoscopy.Due to the recurrent gi bleeding, the patient had a computed tomography (ct) scan of the abdomen and pelvis resulting in the patient undergoing a colonoscopy.During the colonoscopy, it showed arteriovenous malformations (avms) that were clipped with resolution of the bleeding.Post colonoscopy, the patient¿s hemoglobin remained stable at 8.5 g/dl.The patient gave consent to initiate dialysis.Hd was initiated using a permacath 14.5-fr dual lumen catheter for vascular access.The patient was dialyzed with the fresenius f180nr optiflux polysulfone hemodialysis membranes dialyzer.The patient¿s pre-dialysis platelet count was 233×103 /¿l.Three hours after termination of the patient¿s first treatment, the platelet count fell and measured 81×103 /¿l.This drop was not associated with fever, chills, hypotension, or shortness of breath during the treatment.The following day the patient received another hd treatment.The pre and post platelet counts were 100×103 /¿l and 62×103 /¿l, respectively.The patient did not receive dialysis treatments for the next 5 days and their platelet count rose to 216×103 /¿l.Over the course of the patient¿s hospitalization this drop and rise continued pre and post dialysis.The patient¿s lab work was monitored.The suspected cause of the drop in platelet count was a polysulfone dialysis membrane-induced thrombocytopenia.This was due to the strong correlation between the patient¿s dialysis treatments and platelet count decline.Additionally, any abnormalities in the patient¿s bloodwork were related to other causes.Subsequently, the dialyzer was changed on hospital day 40 to the nipro cellentia-17h cellulose triacetate single-use, hollow-fiber, high-flux, hemodialyzer.The patient received three hd treatments over the following week with this dialyzer in which the platelet count rose to 120×103 /¿l.The change to the cellulose dialyzer resolved the patient¿s thrombocytopenia and their platelet count remained stable after discharge.
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Manufacturer Narrative
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Additional information: a1, a2, b5 plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.This event was reported in the american journal of case reports, and thus, a customer account number was not provided.Without a customer account number, an sap delivery search could not be performed and a lot number was not identified.As a result, a lot history review or a lot record review could not be performed.This is considered to be an isolated event.In the last 18 months, this is the only complaint received related to thrombocytopenia.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.
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Event Description
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Fresenius was made aware of an article published in the july 2021 issue of the american journal of case reports which documents a dialyzer reaction.The journal article, ¿thrombocytopenia induced by polysulfone dialysis membranes¿, captured the dialyzer reaction experienced by a patient initiated on hemodialysis (hd).This patient presented to the hospital with weakness, melena, and fatigue and was admitted (unknown date) for recurrent gastrointestinal (gi) bleeding and acute kidney injury.The patient had a history of stage 5 chronic kidney disease.Upon admission to the hospital, the patient¿s hemoglobin was 4.9 g/dl.The patient received red blood cell transfusions (amount unknown) which increased their hemoglobin to a threshold of 7g/dl.One year prior to this hospitalization, the patient required a right hemicolectomy due to a cecal perforation caused during a colonoscopy.Due to the recurrent gi bleeding, the patient had a computed tomography (ct) scan of the abdomen and pelvis resulting in the patient undergoing a colonoscopy.During the colonoscopy, it showed arteriovenous malformations (avms) that were clipped with resolution of the bleeding.Post colonoscopy, the patient¿s hemoglobin remained stable at 8.5 g/dl.The patient gave consent to initiate dialysis.Hd was initiated using a permacath 14.5-fr dual lumen catheter for vascular access.The patient was dialyzed with the fresenius f180nr optiflux polysulfone hemodialysis membranes dialyzer.The patient¿s pre-dialysis platelet count was 233×103 /l.Three hours after termination of the patient¿s first treatment, the platelet count fell and measured 81×103 /l.This drop was not associated with fever, chills, hypotension, or shortness of breath during the treatment.The following day the patient received another hd treatment.The pre and post platelet counts were 100×103 /l and 62×103 /l, respectively.The patient did not receive dialysis treatments for the next 5 days and their platelet count rose to 216×103 /l.Over the course of the patient¿s hospitalization this drop and rise continued pre and post dialysis.The patient¿s lab work was monitored.The suspected cause of the drop in platelet count was a polysulfone dialysis membrane-induced thrombocytopenia.This was due to the strong correlation between the patient¿s dialysis treatments and platelet count decline.Additionally, any abnormalities in the patient¿s bloodwork were related to other causes.Subsequently, the dialyzer was changed on hospital day 40 to the nipro cellentia-17h cellulose triacetate single-use, hollow-fiber, high-flux, hemodialyzer.The patient received three hd treatments over the following week with this dialyzer in which the platelet count rose to 120×103 /l.The change to the cellulose dialyzer resolved the patient¿s thrombocytopenia and their platelet count remained stable after discharge.The patient outlined in the journal article was initiated on hemodialysis (hd) on (b)(6) 2020.The f180nr dialyzer lot numbers were not available from any of the treatments.After the patient¿s initial 2 days of treatment, dialysis was not performed for the following 5 days and then resumed on (b)(6) 2020.Each of the patient¿s subsequent hd treatments were utilizing the f180nr dialyzer until the switch to the cellentia-17h cellulose triacetate dialyzer.
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