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 09/01/2022 |
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 there was smoke coming from the back of a fresenius 2008t hemodialysis (hd) machine during a patient's hemodialysis (hd) treatment.The facility confirmed during follow-up that the patient had already completed treatment and was being disconnected at the time of the reported event.The patient's blood had already been returned and they did not experience an adverse event, serious injury, or require medical intervention nor was there harm to any other individuals because of this malfunction.The biomed stated during follow-up that the issue was contained when the machine was disconnected and removed from the facility.The machine did not trigger the facility's smoke detectors.Upon evaluation the biomed found a melted solenoid valve (valve 103).The machine has approximately 12,000 hours and the valve was the original fresenius part on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the melted valve.The biomed replaced the solenoid valve and the machine was returned to service.The valve was discarded by the biomed and is not available to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Correction: b3 (and not b1 as initially indicated in followup #2).
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Event Description
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A biomedical technician (biomed) at a user facility reported there was smoke coming from the back of a fresenius 2008t hemodialysis (hd) machine during a patient's hemodialysis (hd) treatment.The facility confirmed during follow-up that the patient had already completed treatment and was being disconnected at the time of the reported event.The patient's blood had already been returned and they did not experience an adverse event, serious injury, or require medical intervention nor was there harm to any other individuals because of this malfunction.The biomed stated during follow-up that the issue was contained when the machine was disconnected and removed from the facility.The machine did not trigger the facility's smoke detectors.Upon evaluation the biomed found a melted solenoid valve (valve 103).The machine has approximately 12,000 hours and the valve was the original fresenius part on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the melted valve.The biomed replaced the solenoid valve and the machine was returned to service.The valve was discarded by the biomed and is not available to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Correction: b1.
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Event Description
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A biomedical technician (biomed) at a user facility reported there was smoke coming from the back of a fresenius 2008t hemodialysis (hd) machine during a patient's hemodialysis (hd) treatment.The facility confirmed during follow-up that the patient had already completed treatment and was being disconnected at the time of the reported event.The patient's blood had already been returned and they did not experience an adverse event, serious injury, or require medical intervention nor was there harm to any other individuals because of this malfunction.The biomed stated during follow-up that the issue was contained when the machine was disconnected and removed from the facility.The machine did not trigger the facility's smoke detectors.Upon evaluation the biomed found a melted solenoid valve (valve 103).The machine has approximately 12,000 hours and the valve was the original fresenius part on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the melted valve.The biomed replaced the solenoid valve and the machine was returned to service.The valve was discarded by the biomed and is not available to be returned to the manufacturer for physical 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.The manufacturer investigation determined a causal relationship between the objective evidence and the alleged event; therefore the alleged event is confirmed.
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Event Description
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A biomedical technician (biomed) at a user facility reported there was smoke coming from the back of a fresenius 2008t hemodialysis (hd) machine during a patient's hemodialysis (hd) treatment.The facility confirmed during follow-up that the patient had already completed treatment and was being disconnected at the time of the reported event.The patient's blood had already been returned and they did not experience an adverse event, serious injury, or require medical intervention nor was there harm to any other individuals because of this malfunction.The biomed stated during follow-up that the issue was contained when the machine was disconnected and removed from the facility.The machine did not trigger the facility's smoke detectors.Upon evaluation the biomed found a melted solenoid valve (valve 103).The machine has approximately 12,000 hours and the valve was the original fresenius part on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the melted valve.The biomed replaced the solenoid valve and the machine was returned to service.The valve was discarded by the biomed and is not available to be returned to the manufacturer for physical evaluation.
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Search Alerts/Recalls
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