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 3,415 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: d9, h3 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 on the power control board.Varistors are used to protect a circuit from high voltage surges.There is no other damage found on the power supply, power control board, and nearby components.The power supply was installed (in as-received condition) into a test machine for testing.No problems were encountered during the initial power up.Dialysis mode was run and functioned properly without failures.The self-test program was also completed without failures.There was no thermal event (spark and smoke) and no additional damage encountered during testing.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 reported event has been confirmed.
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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 3,415 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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Search Alerts/Recalls
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