Catalog Number UNKNOWN- 2008 MACHINE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Syncope/Fainting (4411)
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Event Date 01/01/2021 |
Event Type
Injury
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Event Description
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A reddit social media user reported experiencing a syncopic episode while attempting to weigh out at the end of treatment after dialyzing on an unspecified fresenius 2008 hemodialysis (hd) machine.The user reported difficulty with getting their blood pressure up and getting stabilized, which resulted in a trip to the emergency room (er) and being treated with midocrine on dialysis days.The user also noted in their social media post that their blood pressure has recently been increasing (hypertension) during dialysis.Due to the anonymous nature of this social media post, follow up was not possible as no patient information, clinic identification or product(s) serial number was provided in the posting.There was no specific allegation these events were due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.
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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: there is no indication from the provided information that these events were related to the performance of any fresenius product(s) or device(s).Presently there is no allegation or objective evidence indicating a serious injury, patient death, or other adverse event(s) occurred related to a fresenius product(s) or device(s) warranting further investigation.Additionally, there is no allegation a fresenius product(s) or device(s) deficiency or malfunction caused or contributed to the patient¿s syncope, blood pressure complications or emergency department visit.
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Event Description
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A reddit social media user reported experiencing a syncopic episode while attempting to weigh out at the end of treatment after dialyzing on an unspecified fresenius 2008 hemodialysis (hd) machine.The user reported difficulty with getting their blood pressure up and getting stabilized, which resulted in a trip to the emergency room (er) and being treated with midocrine on dialysis days.The user also noted in their social media post that their blood pressure has recently been increasing (hypertension) during dialysis.Due to the anonymous nature of this social media post, follow up was not possible as no patient information, clinic identification or product(s) serial number was provided in the posting.There was no specific allegation these events were due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.
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Manufacturer Narrative
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Correction: h6 (health effect clinical code, addition of hypertension/high blood pressure).
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Manufacturer Narrative
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Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.A causal relationship between the objective evidence and the alleged event could not be determined; therefore the alleged event is unconfirmed.A definitive conclusion regarding the reported incident could not be reached.
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Event Description
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A reddit social media user reported experiencing a syncopic episode while attempting to weigh out at the end of treatment after dialyzing on an unspecified fresenius 2008 hemodialysis (hd) machine.The user reported difficulty with getting their blood pressure up and getting stabilized, which resulted in a trip to the emergency room (er) and being treated with midocrine on dialysis days.The user also noted in their social media post that their blood pressure has recently been increasing (hypertension) during dialysis.Due to the anonymous nature of this social media post, follow up was not possible as no patient information, clinic identification or product(s) serial number was provided in the posting.There was no specific allegation these events were due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.
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Search Alerts/Recalls
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