ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number UNKNOWN- FMC BLOODLINE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Anxiety (2328)
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Event Date 05/20/2020 |
Event Type
Injury
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Manufacturer Narrative
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Plant investigation: the sample was not returned to the manufacturer and the product information was not provided.A search was performed on the products shipped to the facility for a three (3) month time frame immediately preceding the event occurrence date.The search results revealed that no combi set bloodlines were delivered during that time frame.Therefore, a manufacturing review could not be performed and neither could a device history records (dhr) review.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Clinical investigation: a temporal relationship exists between hd therapy utilizing the fresenius combi set bloodlines and the serious adverse events of hypersensitivity/allergic reaction, wheezing and anxiety, which required emergent discontinuation of hd therapy.The definitive etiology of the events is unknown; therefore, causality cannot be firmly established.The patient was utilizing a non-fresenius dialyzer in conjunction with the fresenius combi set bloodlines when the events occurred.Furthermore, the patient¿s wheezing and anxiety during treatment were remediated through the use of benadryl and steroids prior to treatment.Therefore, a possible causal or contributory role cannot be excluded.Based on the information available, the fresenius combi set bloodlines cannot be disassociated from the events.While uncommon, hypersensitivity reactions are known to occur with the use of optiflux dialyzers and/or other elements in the extracorporeal circuit.
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Event Description
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It was reported that a hemodialysis (hd) patient experienced a suspected allergic reaction (per the nephrologist) to the fresenius combi set bloodlines.Follow-up with the patient¿s inpatient dialysis program manager (idpm) revealed the patient was hospitalized on (b)(6) 2020 for hyperkalemia, acute kidney failure (due to cancer, specifics not provided) and dyspnea.On (b)(6) 2020, the patient underwent a temporary hemodialysis (hd) catheter (not a fresenius product) placement and was started on intermittent hd while being monitored by telemetry in the intensive care unit (icu).The patient was alert and oriented, and after hd was initiated on (b)(6) 2020, the patient underwent hd therapy utilizing the fresenius combi set bloodlines and a baxter revaclear dialyzer.The patient began wheezing and feeling an overwhelming sense of anxiety or ¿impending doom.¿ the patient¿s treatment was discontinued.On (b)(6) 2020, the patient was transitioned to continuous veno-venous hemodialysis (cvvh) utilizing a baxter prisma flex and again experienced a similar outcome.The patient¿s condition is unstable, and they require renal replacement therapy to survive.Therefore, the patient is now undergoing intermittent hd utilizing the baxter revaclear dialyzer, after receiving intravenous benadryl and steroids (dose not provided) prior to each hd treatment.Additionally, the specific cause of the reactions isn¿t known; therefore, 3 liters of normal saline is utilized to rinse both the baxter revaclear dialyzer and fresenius combi set bloodlines before each treatment (unknown number of treatments).The idpm reported the patient remains hospitalized and is tolerating hd well considering their status.The patient¿s need for intermittent hd is monitored and ordered on a day to day basis.The treatment record was requested; however, the request was declined.The combi set product information was not provided.
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