CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog 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 03/18/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Plant investigation: 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 prompted with a bicarb pump no eos error message.The machine was opened and the bmt smelled something burnt.After checking the bicarb pump cable/connections and distribution board the bmt saw the connections were burnt and hard to remove and separate.The back of the distribution board at the bicarb connections had burnt marks and were semi-melted.There was no smoke, spark, or flame observed.There was no patient involvement or patient injury noted.Upon follow-up, the bmt confirmed the reported event and stated the issue was noted during rinse mode of preventative maintenance.The bmt confirmed 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 30,000 hours and the bicarb pump and distribution board were not the original fresenius parts on the machine.The machine has not had any past problems with failing the electrical leakage test and there was no damage observed on any other components.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.Per bmt the machine is still out of service pending receipt of the replacement bicarb pump and distribution board parts.The bmt stated the bicarb pump and distribution board were available to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Additional information: d9, h3 plant investigation: no parts were returned to the manufacturer for physical evaluation.The product was not returned; a physical investigation could not be performed.Complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.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 able to be confirmed.
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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 prompted with a bicarb pump no eos error message.The machine was opened and the bmt smelled something burnt.After checking the bicarb pump cable/connections and distribution board the bmt saw the connections were burnt and hard to remove and separate.The back of the distribution board at the bicarb connections had burnt marks and were semi-melted.There was no smoke, spark, or flame observed.There was no patient involvement or patient injury noted.Upon follow-up, the bmt confirmed the reported event and stated the issue was noted during rinse mode of preventative maintenance.The bmt confirmed 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 30,000 hours and the bicarb pump and distribution board were not the original fresenius parts on the machine.The machine has not had any past problems with failing the electrical leakage test and there was no damage observed on any other components.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.Per bmt the machine is still out of service pending receipt of the replacement bicarb pump and distribution board parts.The bmt stated the bicarb pump and distribution board were available to be returned to the manufacturer for physical evaluation.
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Search Alerts/Recalls
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