CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 190766 |
Device Problems
Thermal Decomposition of Device (1071); Melted (1385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/08/2022 |
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 (biomed) at a user facility reported that the power control board of a fresenius 2008t hemodialysis (hd) machine was blackened and melted.A burning smell could also be observed.The reported issue was discovered during machine repair after the machine was initially removed from service for alarming with a 24v low error that occurred during rinse and start up.The biomed initially stated that the power logic and power supply assembly required replacement after the fuses and resistors on the power logic board burned and failed.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 24,375 hours.The biomed reported that there was no additional damage observed on any other components, or any other additional issues, associated with the burned and melted power controller board.The biomed replaced the power supply assembly as well as the motherboard, power logic board, and functional board.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The complaint samples were discarded by the biomed and are not 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 determined that there is a causal relationship between the objective evidence and the alleged event; therefore the alleged event is confirmed.
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Event Description
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A biomedical technician (biomed) at a user facility reported that the power control board of a fresenius 2008t hemodialysis (hd) machine was blackened and melted.A burning smell could also be observed.The reported issue was discovered during machine repair after the machine was initially removed from service for alarming with a 24v low error that occurred during rinse and start up.The biomed initially stated that the power logic and power supply assembly required replacement after the fuses and resistors on the power logic board burned and failed.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 24,375 hours.The biomed reported that there was no additional damage observed on any other components, or any other additional issues, associated with the burned and melted power controller board.The biomed replaced the power supply assembly as well as the motherboard, power logic board, and functional board.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The complaint samples were discarded by the biomed and are not available to be returned to the manufacturer for physical evaluation.
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