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
Melted (1385); Smoking (1585)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2022 |
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 melted valve 103.The valve 103 was very hot and the melting dripped down onto the bibag hydraulic assembly and cable.A burning smell and significant smoke was noticed during setup for patient treatment.The smoke caused the detectors to go off and the fire department arrived at the user facility.The machine was taken outside to cool off and air out before being brought back into the user facility and quarantined.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 26,652 hours and the valve 103 was the original fresenius part on the machine.The biomed did not observe any spark, flame, arcing, or any other visible heat or electrical damage related to the melting found on the valve.The biomed confirmed that the machine has not had any past problems with failing the electrical leakage test and is always plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed ordered replacement valve 103, bibag hydraulic assembly, and cable but not all parts have arrived to resolve the issue.Therefore, the unit has not been returned to service.The original parts are 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: although it was stated that the complaint device was available to be returned, to date 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 into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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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 melted valve 103.The valve 103 was very hot and the melting dripped down onto the bibag hydraulic assembly and cable.A burning smell and significant smoke was noticed during setup for patient treatment.The smoke caused the detectors to go off and the fire department arrived at the user facility.The machine was taken outside to cool off and air out before being brought back into the user facility and quarantined.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 26,652 hours and the valve 103 was the original fresenius part on the machine.The biomed did not observe any spark, flame, arcing, or any other visible heat or electrical damage related to the melting found on the valve.The biomed confirmed that the machine has not had any past problems with failing the electrical leakage test and is always plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed ordered replacement valve 103, bibag hydraulic assembly, and cable but not all parts have arrived to resolve the issue.Therefore, the unit has not been returned to service.The original parts are available to be returned to the manufacturer for physical evaluation.
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