CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 191126 |
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 12/01/2021 |
Event Type
malfunction
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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 v104 stuck open alarm.Upon follow up, biomed confirmed the reported product complaint.Biomed stated that a 2008t machine was failing functional tests outside of therapy due to the v104 alarm.Biomed stated that upon troubleshooting the machine issue, the field service technician (fst) found that the ribbon cable on the bibag assembly was burned and a burning smell was detected at that time.Biomed did not observe any smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burned ribbon cable.Biomed could not confirm the machine hours but the cable and assembly were the original fresenius parts on the machine.Biomed reported 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.Biomed stated that the entire bibag assembly including the cable was replaced by the fst, which resolved the machine issue, and that the machine is back in service without any issues.Additionally, biomend confirmed that there was no damage observed on any other components, or any other additional issues, associated with the burned cable.Biomed confirmed that 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.Biomed confirmed that the fst picked up the damaged cable and assembly.Upon further follow up, the fst confirmed that the damaged part has been returned to the manufacturer for physical analysis.
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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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Additional information: d9, h3 plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).To resolve the reported issue, the fst replaced the entire bibag assembly including the cable.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 confirm the reported failure mode.During the machine inspection, the fresenius fst identified a burned cable.Therefore, the complaint event was 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 v104 stuck open alarm.Upon follow up, biomed confirmed the reported product complaint.Biomed stated that a 2008t machine was failing functional tests outside of therapy due to the v104 alarm.Biomed stated that upon troubleshooting the machine issue, the field service technician (fst) found that the ribbon cable on the bibag assembly was burned and a burning smell was detected at that time.Biomed did not observe any smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burned ribbon cable.Biomed could not confirm the machine hours but the cable and assembly were the original fresenius parts on the machine.Biomed reported 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.Biomed stated that the entire bibag assembly including the cable was replaced by the fst, which resolved the machine issue, and that the machine is back in service without any issues.Additionally, biomend confirmed that there was no damage observed on any other components, or any other additional issues, associated with the burned cable.Biomed confirmed that 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.Biomed confirmed that the fst picked up the damaged cable and assembly.Upon further follow up, the fst confirmed that the damaged part has been returned to the manufacturer for physical analysis.
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Manufacturer Narrative
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Additional information: d9, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.The gen2 bibag assembly was returned with thermal damage to the gen2 hydraulics distribution cable.The connection on the cable for pins 1, 2, 3, and 4 for j1 connector of the gen2 hydraulic distribution board is charred with broken wires.There are signs of concentrate (fluid leak) on the connector.There is thermal damage on the gen2 hydraulics distribution board.Pins 1, 2, 3, and 4 of j1 connector is charred with signs of concentrate.There are also signs of concentrate on the back of the distribution board where pins 1, 2, 3, and 4 of j1 connector are located.The plug of valve 105 that connects to j2 of the distribution board is also charred, however, the pins of j2 connector on the distribution board are not damaged.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, the thermal event was caused by shorted components due to concentrate on j1 connector and cable.The concentrate can cause a short between the pins, resulting in thermal damage.
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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 v104 stuck open alarm.Upon follow up, biomed confirmed the reported product complaint.Biomed stated that a 2008t machine was failing functional tests outside of therapy due to the v104 alarm.Biomed stated that upon troubleshooting the machine issue, the field service technician (fst) found that the ribbon cable on the bibag assembly was burned and a burning smell was detected at that time.Biomed did not observe any smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burned ribbon cable.Biomed could not confirm the machine hours but the cable and assembly were the original fresenius parts on the machine.Biomed reported 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.Biomed stated that the entire bibag assembly including the cable was replaced by the fst, which resolved the machine issue, and that the machine is back in service without any issues.Additionally, biomend confirmed that there was no damage observed on any other components, or any other additional issues, associated with the burned cable.Biomed confirmed that 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.Biomed confirmed that the fst picked up the damaged cable and assembly.Upon further follow up, the fst confirmed that the damaged part has been returned to the manufacturer for physical analysis.
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