CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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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 12/27/2022 |
Event Type
malfunction
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Event Description
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A user facility biomedical technician (biomed) reported that a 2008t hemodialysis (hd) machine had a burn mark on the distribution board.Prior to discovering this, the machine was giving a message indicating the temperature was exceeding 95 degrees celsius following a heat disinfect cycle.In addition to the burn mark on the distribution board, the biomed found corrosion on the heater rod.No damage was identified on any other components.The biomed replaced the heater rod and the distribution board to resolve the issue.It was confirmed that the distribution board was an original fresenius part.The biomed confirmed there was no burning smell or smoke.Additionally, there were no signs of any sparks, or flames.The machine had approximately 45,000 hours on it.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.The biomed confirmed the machine was returned to service.The damaged distribution board was not available to be returned for evaluation because the biomed discarded it.There were also no photos available.The biomed confirmed there was no patient involvement associated with the event.
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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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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation and an on-site evaluation was not performed by a fresenius field service technician (fst).However, the manufacturer was able to determine a causal relationship between the objective evidence provided by the customer and the reported event.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 that a 2008t hemodialysis (hd) machine had a burn mark on the distribution board.Prior to discovering this, the machine was giving a message indicating the temperature was exceeding 95 degrees celsius following a heat disinfect cycle.In addition to the burn mark on the distribution board, the biomed found corrosion on the heater rod.No damage was identified on any other components.The biomed replaced the heater rod and the distribution board to resolve the issue.It was confirmed that the distribution board was an original fresenius part.The biomed confirmed there was no burning smell or smoke.Additionally, there were no signs of any sparks, or flames.The machine had approximately 45,000 hours on it.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.The biomed confirmed the machine was returned to service.The damaged distribution board was not available to be returned for evaluation because the biomed discarded it.There were also no photos available.The biomed confirmed there was no patient involvement associated with the event.
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