Clinical review: there was no allegation of a device malfunction or deficiency reported for the event.Fluid volume overload can reflect a combination of inappropriate prescription, noncompliance, loss of residual renal function, mechanical problems, and peritoneal membrane dysfunction.Without additional information, the cause of the patient¿s fluid overload cannot be determined; however, there is no indication of a serious injury, patient death, or other adverse event.Plant investigation: no parts were returned to the manufacturer for physical evaluation.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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