CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 190766 |
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 06/13/2022 |
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 a fresenius 2008t hemodialysis (hd) machine had a motherboard that shorted out.The air-conditioning was down and not working at the clinic, and due to the weather being so hot, there was a lot of moisture building up.Somehow, moisture had dripped down to the motherboard, causing it to short out and, in turn, alarmed a ¿bibag: door error¿ message.The moisture left a discoloration mark on the board, but the biomed was not sure if that mark was a burn mark or a charred mark.The biomed confirmed the part seized out and would no longer work.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 biomed stated that he did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to burn damage found on the motherboard.The biomed stated that the machine has approximately 20,000 hours and that the motherboard is the original fresenius part on the machine.The biomed stated that the motherboard was replaced, which resolved the machine issue, and that the machine is back in service without any issues.Additionally, the biomed confirmed that there was no damage observed on any other components, or any other additional issues, associated with the burned motherboard.The biomed confirmed that the motherboard was discarded and unavailable for return 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 was 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 a fresenius 2008t hemodialysis (hd) machine had a motherboard that shorted out.The air-conditioning was down and not working at the clinic, and due to the weather being so hot, there was a lot of moisture building up.Somehow, moisture had dripped down to the motherboard, causing it to short out and, in turn, alarmed a ¿bibag: door error¿ message.The moisture left a discoloration mark on the board, but the biomed was not sure if that mark was a burn mark or a charred mark.The biomed confirmed the part seized out and would no longer work.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 biomed stated that he did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to burn damage found on the motherboard.The biomed stated that the machine has approximately 20,000 hours and that the motherboard is the original fresenius part on the machine.The biomed stated that the motherboard was replaced, which resolved the machine issue, and that the machine is back in service without any issues.Additionally, the biomed confirmed that there was no damage observed on any other components, or any other additional issues, associated with the burned motherboard.The biomed confirmed that the motherboard was discarded and unavailable for return to the manufacturer for physical evaluation.
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