Catalog Number UNKNOWN- 2008T MACHINE |
Device Problem
Inadequate Ultra Filtration (1656)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2022 |
Event Type
malfunction
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Event Description
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A user facility biomedical technician (biomed) reported to a fresenius clinical support specialist that a 2008 machine (model unknown) which was recently upgraded with bluestar software is not holding the programmed ultrafiltration (uf) goal and time settings.The settings were programmed to a uf goal of 2.5 liters and a uf time of 4 hours.The biomed stated that a second person visually verified the programmed settings to ensure that they were correct.However a few minutes after the initiation of treatment the machine reverts back to the default settings of 3 liters and 3 hours.Additional information was requested, however a response has not been received.There was no indication that the patient experienced a serious injury, adverse event, or required medical intervention as a result of the reported issue.It was indicated on the initial report that the patient was not able to complete treatment with the fresenius products and devices that were originally provided.No parts were returned to the manufacturer for a physical evaluation.
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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).A records review could not be performed as the reported serial number was not reported.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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Manufacturer Narrative
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Correction: d4 (catalog number).
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Event Description
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A user facility biomedical technician (biomed) reported to a fresenius clinical support specialist that a 2008 machine (model unknown) which was recently upgraded with bluestar software is not holding the programmed ultrafiltration (uf) goal and time settings.The settings were programmed to a uf goal of 2.5 liters and a uf time of 4 hours.The biomed stated that a second person visually verified the programmed settings to ensure that they were correct.However a few minutes after the initiation of treatment the machine reverts back to the default settings of 3 liters and 3 hours.Additional information was requested, however a response has not been received.There was no indication that the patient experienced a serious injury, adverse event, or required medical intervention as a result of the reported issue.It was indicated on the initial report that the patient was not able to complete treatment with the fresenius products and devices that were originally provided.No parts were returned to the manufacturer for a physical evaluation.
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Search Alerts/Recalls
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