Catalog Number 190713 |
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 04/01/2024 |
Event Type
malfunction
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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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It was reported to fresenius technical services that treatment on the 2008t machine ended five minutes early.The machine will start correctly and slowly lose time over the course of treatment.This issue affects both the ultrafiltration (uf) time and treatment end time.There are no diagnostic messages or audible alarms associated with the reported issue.The patient was able to complete treatment.There was no adverse event, serious injury, or required medical intervention as a result of the reported issue.The fresenius technical services representative explained that the treatment end time on the trends screen corresponds with the remaining time to dialyze (rtd) on the home screen.Any changes to rtd will affect treatment end time.Then technical services referred the customer to the regional sales manager to be put in touch with the local clinical consultant.The customer was advised to swap the function board if the clinical consultant could not assist and this machine continued to experience this issue.Additional information was requested however a response was not received.No parts were returned to the manufacturer for 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 was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The complaint investigation did not find objective evidence indicating a product problem, thus the complaint is unconfirmed.
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Event Description
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It was reported to fresenius technical services that treatment on the 2008t machine ended five minutes early.The machine will start correctly and slowly lose time over the course of treatment.This issue affects both the ultrafiltration (uf) time and treatment end time.There are no diagnostic messages or audible alarms associated with the reported issue.The patient was able to complete treatment.There was no adverse event, serious injury, or required medical intervention as a result of the reported issue.The fresenius technical services representative explained that the treatment end time on the trends screen corresponds with the remaining time to dialyze (rtd) on the home screen.Any changes to rtd will affect treatment end time.Then technical services referred the customer to the regional sales manager to be put in touch with the local clinical consultant.The customer was advised to swap the function board if the clinical consultant could not assist and this machine continued to experience this issue.Additional information was requested however a response was not received.No parts were returned to the manufacturer for physical evaluation.
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Search Alerts/Recalls
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