Catalog Number 191126 |
Device Problems
Smoking (1585); Sparking (2595)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 07/27/2023 |
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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A user facility biomedical technician (biomed) reported to fresenius technical services that smoke and a spark were observed from the power supply of a 2008t machine.The reported issue occurred after the entire facility lost power during a thunderstorm.The machine shutdown during a patient¿s hemodialysis (hd) treatment.Power was restored to the facility but the machine could not be powered back on.An electrician was called to inspect the outlets to verify they are safe for machine usage.The clinic manager (cm) provided additional information during follow-up.The patient was immediately pulled from the machine when the reported event occurred.The patient could not be reinfused.The patient¿s estimated blood loss (ebl) was not provided.The patient did not experience a serious injury, adverse event, or require medical intervention.The patient¿s treatment ended for the day.Additional information was requested however a response was not received.No parts were returned to the manufacturer for physical evaluation.
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Event Description
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A user facility biomedical technician (biomed) reported to fresenius technical services that smoke and a spark were observed from the power supply of a 2008t machine.The reported issue occurred after the entire facility lost power during a thunderstorm.The machine shutdown during a patient¿s hemodialysis (hd) treatment.Power was restored to the facility but the machine could not be powered back on.An electrician was called to inspect the outlets to verify they are safe for machine usage.The clinic manager (cm) provided additional information during follow-up.The patient was immediately pulled from the machine when the reported event occurred.The patient could not be reinfused.The patient¿s estimated blood loss (ebl) was not provided.The patient did not experience a serious injury, adverse event, or require medical intervention.The patient¿s treatment ended for the day.A fresenius field service technician (fst) was called onsite to evaluate the machine.The repair details indicate that the machine has 4.743 hours.The reported power issue could be duplicated as the machine would not power on.The power supply was replaced to resolve this issue.The machine passed all functional testing.No parts were returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Additional information: b5, d9.
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Event Description
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A user facility biomedical technician (biomed) reported to fresenius technical services that smoke and a spark were observed from the power supply of a 2008t machine.The reported issue occurred after the entire facility lost power during a thunderstorm.The machine shutdown during a patient¿s hemodialysis (hd) treatment.Power was restored to the facility but the machine could not be powered back on.An electrician was called to inspect the outlets to verify they are safe for machine usage.The clinic manager (cm) provided additional information during follow-up.The patient was immediately pulled from the machine when the reported event occurred.The patient could not be reinfused.The patient¿s estimated blood loss (ebl) was not provided.The patient did not experience a serious injury, adverse event, or require medical intervention.The patient¿s treatment ended for the day.A fresenius field service technician (fst) was called onsite to evaluate the machine.The repair details indicate that the machine has 4.743 hours.The reported power issue could be duplicated as the machine would not power on.The power supply was replaced to resolve this issue.The machine passed all functional testing.No parts were returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Plant investigation: the power supply was returned to the manufacturer for physical evaluation.An initial inspection on the returned power supply found thermal damage to varistor (rv1) and soot on the power control board.There is no other damage found on the power supply, power control board, and nearby components.The damaged varistor (rv1) was found to be shorted which can cause sparks and smoke on varistor (rv1).Varistor (rv1) was replaced on the power control board for testing.The power supply (reworked) was installed to test machine for testing.The test machine powered up without failures.Rinse program completed without problems.Dialysis mode functioned properly without any failures.A self-test program completed without any failures.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 investigation into the cause of the reported problem was able to confirm the reported failure mode.
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Search Alerts/Recalls
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