Model Number 0500316E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
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Event Date 03/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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The plant and clinical investigations are in process.A supplemental mdr will be submitted upon completion of these activities. .
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Event Description
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It was reported to fresenius that the patient experiences itching after completing hemodialysis (hd) treatment with the optiflux 160nre dialyzer.There is no serious injury, adverse event, or medical intervention required regarding the reported issue.The itching is the extent of the patient¿s reaction and they do not experience any additional symptoms.The patient also does not take any over-the-counter (otc) medication in order to address the allergic reaction.The patient has been switched to a non-fresenius brand dialyzer temporarily.The complaint sample is not available to be returned to the manufacturer for a physical evaluation.
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Manufacturer Narrative
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Additional information: h10 (clinical investigation) clinical investigation: based on the available information, there is a temporal and a likely causal relationship between the fresenius optiflux 160nre dialyzer and the patient¿s itching following the completion of hemodialysis treatments.Although rare, hypersensitivity reactions, such as itching, to the dialyzer may occur during hemodialysis.This is a known risk factor.It is unknown if the patient¿s itching resolved with the transition to the non-fresenius dialyzer.Despite the patient¿s reaction to the optiflux 160nre dialyzer resulting in itching, there is no evidence or allegation of a fresenius optiflux 160nre dialyzer malfunction or deficiency reported for this event.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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It was reported to fresenius that the patient experiences itching after completing hemodialysis (hd) treatment with the optiflux 160nre dialyzer.There is no serious injury, adverse event, or medical intervention required regarding the reported issue.The itching is the extent of the patient¿s reaction and they do not experience any additional symptoms.The patient also does not take any over-the-counter (otc) medication in order to address the allergic reaction.The patient has been switched to a non-fresenius brand dialyzer temporarily.The complaint sample is not available to be returned to the manufacturer for a physical evaluation.
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Event Description
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It was reported to fresenius that the patient experiences itching after completing hemodialysis (hd) treatment with the optiflux 160nre dialyzer.There is no serious injury, adverse event, or medical intervention required regarding the reported issue.The itching is the extent of the patient¿s reaction and they do not experience any additional symptoms.The patient also does not take any over-the-counter (otc) medication in order to address the allergic reaction.The patient has been switched to a non-fresenius brand dialyzer temporarily.The complaint sample is not available to be returned to the manufacturer for a physical evaluation.
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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.As no lot number was provided for this complaint, an search was performed to obtain all lot numbers with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.Seven lots were found to have been delivered in this time period.A production records review was performed on the reported lots.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on the lots and one nonconformance on one of the lots which were 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 lots 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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Search Alerts/Recalls
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