Model Number 190713 |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2021 |
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 biomedical technician (bmt) at a user facility reported a fresenius 2008t hemodialysis (hd) machine had a burnt ui - mics board when they tried to load chairside.The bmt reported there was no smoke, spark, or flame observed.The burned actuator board was noticed during dialysis mode of preventative maintenance and a patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The machine has approximately 21,000 hours and the ui - mics board was the original fresenius part on the machine.Per bmt a replacement ui - mics board was ordered and is pending receipt.The bmt reported the machine remains out of service.The bmt reported that the ui - mics board component was no longer available to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Correction: b5.
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Event Description
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A biomedical technician (bmt) at a user facility reported a fresenius 2008t hemodialysis (hd) machine had a burnt ui - mics board when they tried to load chairside.The bmt reported there was no smoke, spark, or flame observed.The burned ui - mics board was noticed during dialysis mode of preventative maintenance and a patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The machine has approximately 21,000 hours and the ui - mics board was the original fresenius part on the machine.Per bmt a replacement ui - mics board was ordered and is pending receipt.The bmt reported the machine remains out of service.The bmt reported that the ui - mics board component was no longer available to be 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 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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Event Description
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A biomedical technician (bmt) at a user facility reported a fresenius 2008t hemodialysis (hd) machine had a burnt ui - mics board when they tried to load chairside.The bmt reported there was no smoke, spark, or flame observed.The burned ui - mics board was noticed during dialysis mode of preventative maintenance and a patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The machine has approximately 21,000 hours and the ui - mics board was the original fresenius part on the machine.Per bmt a replacement ui - mics board was ordered and is pending receipt.The bmt reported the machine remains out of service.The bmt reported that the ui - mics board component was no longer available to be returned to the manufacturer for physical evaluation.
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Search Alerts/Recalls
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