CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 190713 |
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 02/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Though production and device history record (dhr) reviews were completed, the plant investigation is still in process.A supplemental mdr will be submitted upon completion of this activity.Plant investigation: 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.
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Event Description
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A user facility biomedical technician (biomed) reported finding thermal damage on multiple components in a fresenius 2008t hemodialysis (hd) machine.The biomed reportedly heard a squeak coming from the machines bicarbonate pump.The biomed subsequently replaced the bicarbonate pump assembly.Afterwards, when the biomed turned on the unit, a loud pop was heard followed by a burning smell.However, the unit still ran, so the biomed put the machine in rinse mode.During rinse, the biomed reported that a bicarb pump no end of stroke (eos) message appeared.Upon investigation, the biomed found a piece of heating rod coil wiring that was exposed from rubbing against the bicarb pump.This reportedly caused the bicarb ribbon cable to melt.The heating rod cable also looked worn.The biomed stated that it looked like the cable burned and caused the actuator board to go.The actuator board had noticeable burn damage on the legs of the icu chip (ic19).There was no sign of any smoke, sparks, flames, charring, or arcing.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test.The biomed estimated that the machine had 6,000 hours logged at the time of the event.The biomed also reported that the machine passes preventive maintenance (pm) checks when they are due.To resolve the reported issue, the biomed replaced the actuator board, the heating rod, and the bicarb pump.There was no patient involvement associated with the reported event.Photographs of the thermal damage were provided by the biomed.Though the replaced parts were reportedly retained, the biomed has not yet agreed to send them back for manufacturer 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.Although no parts were returned for evaluation, photographs of the thermal damage were provided for review.Based on the provided photographs, the reported event was able to be confirmed.
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Event Description
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A user facility biomedical technician (biomed) reported finding thermal damage on multiple components in a fresenius 2008t hemodialysis (hd) machine.The biomed reportedly heard ¿a squeak¿ coming from the machine¿s bicarbonate pump.The biomed subsequently replaced the bicarbonate pump assembly.Afterwards, when the biomed turned on the unit, a loud pop was heard followed by a burning smell.However, the unit still ran, so the biomed put the machine in rinse mode.During rinse, the biomed reported that a ¿bicarb pump no end of stroke (eos)¿ message appeared.Upon investigation, the biomed found a piece of heating rod coil wiring that was exposed from rubbing against the bicarb pump.This reportedly caused the bicarb ribbon cable to melt.The heating rod cable also looked worn.The biomed stated that it looked like the cable burned and caused the actuator board ¿to go¿.The actuator board had noticeable burn damage on the legs of the icu chip (ic19).There was no sign of any smoke, sparks, flames, charring, or arcing.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test.The biomed estimated that the machine had 6,000 hours logged at the time of the event.The biomed also reported that the machine passes preventive maintenance (pm) checks when they are due.To resolve the reported issue, the biomed replaced the actuator board, the heating rod, and the bicarb pump.There was no patient involvement associated with the reported event.Photographs of the thermal damage were provided by the biomed.Though the replaced parts were reportedly retained, the biomed has not yet agreed to send them back for manufacturer evaluation.
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