A biomedical technician (biomed) at a user facility reported that a fresenius 2008k2 hemodialysis (hd) machine had an acid pump with a burnt ribbon cable.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 issue was discovered after the machine was pulled from service for experiencing issues with low conductivity and the acid pump not stroking.The biomed had removed the acid pump from the machine to rebuild it when the burn damage to the ribbon cable was found.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burned acid pump.The biomed replaced the acid pump, which resolved the issues.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The acid pump was discarded by the biomed and is not available to be returned to the manufacturer for physical evaluation.
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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 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.
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