CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
|
Back to Search Results |
|
Model Number 2008T |
Device Problems
Thermal Decomposition of Device (1071); Smoking (1585); Arcing (2583)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/13/2022 |
Event Type
malfunction
|
Event Description
|
A user facility biomedical technician reported to fresenius technical support that a fresenius 2008t hemodialysis (hd) machine had a burnt actuator board due to arcing from the bicarb pump.The biomedical technician stated that there was a burning smell and smoke, however no melting or flame and the fire alarms did not sound nor were extinguishers necessary.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 35,000 hours and the actuator board and bicarb pump were the original fresenius parts on the machine.The biomedical technician reported that there was no damage observed on any other components, or any other additional issues, associated with the burnt parts.The biomedical technician confirmed that the machine has not had any past problems with failing the electrical leakage test or any other damaged component associated with the damaged actuator board.The biomedical technician stated that the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomedical technician replaced the actuator board and bicarb pump, which resolved the issue.It was confirmed there was no patient involvement associated with the reported issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.No photographs are available.The actuator board and bicarb pump was discarded by the facility and is not available to be returned to the manufacturer for physical evaluation.
|
|
Manufacturer Narrative
|
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
|
|
Manufacturer Narrative
|
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).The investigation determines that there was causal relationship between the objective evidence and the alleged event; the alleged event is confirmed.The complaint is confirmed due to the electrical malfunction from the bicarbonate pump.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 confirmed.
|
|
Event Description
|
A user facility biomedical technician reported to fresenius technical support that a fresenius 2008t hemodialysis (hd) machine had a burnt actuator board due to arcing from the bicarb pump.The biomedical technician stated that there was a burning smell and smoke, however no melting or flame and the fire alarms did not sound nor were extinguishers necessary.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 35,000 hours and the actuator board and bicarb pump were the original fresenius parts on the machine.The biomedical technician reported that there was no damage observed on any other components, or any other additional issues, associated with the burnt parts.The biomedical technician confirmed that the machine has not had any past problems with failing the electrical leakage test or any other damaged component associated with the damaged actuator board.The biomedical technician stated that the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomedical technician replaced the actuator board and bicarb pump, which resolved the issue.It was confirmed there was no patient involvement associated with the reported issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.No photographs are available.The actuator board and bicarb pump was discarded by the facility and is not available to be returned to the manufacturer for physical evaluation.
|
|
Manufacturer Narrative
|
Correction: h6 component code for actuator board.
|
|
Event Description
|
A user facility biomedical technician reported to fresenius technical support that a fresenius 2008t hemodialysis (hd) machine had a burnt actuator board due to arcing from the bicarb pump.The biomedical technician stated that there was a burning smell and smoke, however no melting or flame and the fire alarms did not sound nor were extinguishers necessary.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 35,000 hours and the actuator board and bicarb pump were the original fresenius parts on the machine.The biomedical technician reported that there was no damage observed on any other components, or any other additional issues, associated with the burnt parts.The biomedical technician confirmed that the machine has not had any past problems with failing the electrical leakage test or any other damaged component associated with the damaged actuator board.The biomedical technician stated that the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomedical technician replaced the actuator board and bicarb pump, which resolved the issue.It was confirmed there was no patient involvement associated with the reported issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.No photographs are available.The actuator board and bicarb pump was discarded by the facility and is not available to be returned to the manufacturer for physical evaluation.
|
|
Search Alerts/Recalls
|
|
|