Model Number 190766 |
Device Problems
Thermal Decomposition of Device (1071); Corroded (1131)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/07/2022 |
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 corroded wiring harness and the connected solenoid valve was hot to the touch.The reported issue was identified during machine repair after the machine was pulled from service for alarming with an unspecified message during rinse mode.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 12,000 hours.The solenoid valve was recently replace.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the solenoid valve and wiring harness.The biomed replaced the solenoid valve and wiring harness, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The complaint samples were discarded by the biomed and are not available to be returned to the manufacturer for physical evaluation.
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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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Correction: b1 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 investigation determined that there is 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 that a fresenius 2008t hemodialysis (hd) machine had a corroded wiring harness and the connected solenoid valve was hot to the touch.The reported issue was identified during machine repair after the machine was pulled from service for alarming with an unspecified message during rinse mode.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 12,000 hours.The solenoid valve was recently replace.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the solenoid valve and wiring harness.The biomed replaced the solenoid valve and wiring harness, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The complaint samples were discarded by the biomed and are not available to be returned to the manufacturer for physical evaluation.
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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 corroded wiring harness and the connected solenoid valve was hot to the touch.The reported issue was identified during machine repair after the machine was pulled from service for alarming with an unspecified message during rinse mode.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 12,000 hours.The solenoid valve was recently replace.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the solenoid valve and wiring harness.The biomed replaced the solenoid valve and wiring harness, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The complaint samples were discarded by the biomed and are not available to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Correction: b3 (not b1 as initially indicated in followup #1).
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Search Alerts/Recalls
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