Model Number 190766 |
Device Problems
Thermal Decomposition of Device (1071); Fire (1245); Melted (1385)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
|
|
Event Description
|
A biomedical technician (biomed) at a user facility reported via a social media thread that valve 103 inside of a fresenius 2008t hemodialysis (hd) machine sustained corrosion and caught fire.The event occurred during testing six years prior to making the report.The biomed stated that the screws on the air separator loosened from the module expanding and contracting over time due to repeated heat disinfection cycles.The loosening on the air separator caused a leak onto valve 103 which led to corrosion and the resulting fire.The valve appeared charred, melted, and black.The biomed stated that the smoke detector was not triggered as a result of the fire caused by the burnt valve.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 biomed stated that valve 103, the valve block, and the bibag module were replaced to resolve the reported issue.No parts are 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. .
|
|
Event Description
|
A biomedical technician (biomed) at a user facility reported via a social media thread that valve 103 inside of a fresenius 2008t hemodialysis (hd) machine sustained corrosion and caught fire.The event occurred during testing six years prior to making the report.The biomed stated that the screws on the air separator loosened from the module expanding and contracting over time due to repeated heat disinfection cycles.The loosening on the air separator caused a leak onto valve 103 which led to corrosion and the resulting fire.The valve appeared charred, melted, and black.The biomed stated that the smoke detector was not triggered as a result of the fire caused by the burnt valve.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 biomed stated that valve 103, the valve block, and the bibag module were replaced to resolve the reported issue.No parts are available to be returned to the manufacturer for physical evaluation.
|
|
Event Description
|
A biomedical technician (biomed) at a user facility reported via a social media thread that valve 103 inside of a fresenius 2008t hemodialysis (hd) machine sustained corrosion and caught fire.The event occurred during testing six years prior to making the report.The biomed stated that the screws on the air separator loosened from the module expanding and contracting over time due to repeated heat disinfection cycles.The loosening on the air separator caused a leak onto valve 103 which led to corrosion and the resulting fire.The valve appeared charred, melted, and black.The biomed stated that the smoke detector was not triggered as a result of the fire caused by the burnt valve.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 biomed stated that valve 103, the valve block, and the bibag module were replaced to resolve the reported issue.No parts are available to be returned to the manufacturer for physical evaluation.
|
|
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).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 not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
|
|
Search Alerts/Recalls
|