Model Number 2008K |
Device Problem
Charred (1086)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/09/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.
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Event Description
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The clinic staff reported a burning smell post patient treatment.There were no diagnostic message or alarms reported by the staff.Photographs provided by the complainant indicates evidence of burnt circuitry.The machine was put back into operational use.
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Manufacturer Narrative
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The allegation was not confirmed.The complaint sample was not returned to the plant for investigation.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.
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Event Description
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".".
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Manufacturer Narrative
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Correction: device available for evaluation: the alleged event was confirmed.The component was returned with heat damage to the alleged component.There are no other damage found on the board.The actuator/test board (as-received condition) was tested on a test machine for the reported failure (burning smell).The reported burning smell could not be detected during the initial power up and dialysis mode.There were no further damage done to the board during testing.However, a ¿low flow error¿ was encountered in dialysis.The ¿low flow error¿ was caused by the damaged ic¿s.The component is part of the flow pump circuitry and is part of the deaeration pump circuitry.Both circuitry will cause flow errors.A microscopic view of the damaged board found a lifted trace on the location of component.The reported burning smell was not confirmed.The physical damage is confirmed.Due to the condition of the board, the actuator/test could not be repaired.The device history record did not reveal any issues or problems related to the reported symptom code.The a serial number search in the ptc complaint system found one complaint with the issue of burning smell within 90 days of the notified date.The actuator/test board was returned to return goods for final disposition.
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Event Description
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Search Alerts/Recalls
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