Model Number OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Reaction (2414)
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Event Date 09/06/2018 |
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. .
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Event Description
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A user facility clinical manager reported a patient who broke out in hives for an unspecified number of hemodialysis treatments occurring after (b)(6) 2018 while using fresenius optiflux dialyzers.The clinic manager confirmed the patient had been administered 12.5mg of benadryl intravenously, and remained on the machine to complete treatment, after which their symptoms resolved.The clinic manager advised the patient had not missed any of their scheduled hemodialysis treatments due to the issue.Due diligence attempts were exhausted, but additional patient and device information was not provided.
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Manufacturer Narrative
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Additional information: event description updated.Brand name updated.Medical device -model # and catalog # updated.
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Event Description
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Updated event description: a user facility clinical manager reported a patient who broke out in hives for an unspecified number of hemodialysis treatments occurring after (b)(6) 2018 and before (b)(6) 2018 while using fresenius optiflux 180nr dialyzers.The clinic manager confirmed the patient had been administered 12.5mg of benadryl intravenously prior to treatment, and remained on the machine to complete treatment, after which their symptoms resolved.The clinic manager advised the patient had not missed any of their scheduled hemodialysis treatments due to the issue.
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Manufacturer Narrative
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The reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.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 approved temporary deviation notices (dns) reported on the lot 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 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.
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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: the hemodialysis patient had a medical history of end stage renal disease (esrd).Based on the available information, there is a likely causal association between the fresenius optiflux dialyzer and the patient¿s allergic reaction (characterized by hives during the hd treatment).Although rare, hypersensitivity or anaphylactoid reactions to optiflux dialyzers are a known risk during hemodialysis.There is no evidence of an optiflux dialyzer product deficiency or malfunction reported for this event.
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Manufacturer Narrative
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Updated clinical investigation: additional information was received and reviewed.The new information documented that the patient experienced allergic reactions with their hemodialysis treatments.This event which occurred after (b)(6)2018 was with an unknown optiflux dialyzer.The clinic had tried both the 180nr and 180nre with the same outcome.The patient¿s medications were reviewed and the gloves were ruled out as the cause of the reaction.Prior to start of treatment the patient is administered intravenous (iv) benadryl and the dialyzer is flushed with 2l of normal saline solution.The conclusion of the initial clinical investigation does not change with the additional information provided by the clinic.
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Manufacturer Narrative
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Correction: mfr site, report source additional information: 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, a system search was performed with the provided client id.It was noted that the clinic did not receive dialyzers directly from the fmc-na rtg llc; however, the product may have been purchased through 3rd party vendors.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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