Plant investigation: the actual device was not returned to the manufacturer for physical evaluation.A review of the process controls in place showed all product analysis and checkweigher system requirements were met.The retain sample was pulled and tested for the lot number.The retain was tested for bicarbonate analysis and sodium analysis.All results were found to be within specification.The bicarbonate concentration was found to be 978.1 meq/l, which is within the 943.8 ¿ 992.2 meq/l specification.The sodium concentration was found to be 955.0 meq/l, which is within the 943.8 ¿ 992.2 meq/l specification.Furthermore, there is no out specification for specific gravity or conductivity called out in the release criteria for the manufacturer.A records review was performed on the reported lot 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 lot met all acceptance criteria, and no adverse events were noted during production related to the filler, checkweigher, and/or product laboratory analysis.The investigation into the cause of the reported problem was not able to be confirmed and the probable cause of this event is unknown.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
|
Clinical review: a clinical investigation was performed to identify a causal relationship between the patient's hemodialysis (hd) treatment and the reported vomiting event.A probable cause of event cannot be determined.It was reported patient¿s hypotension may have been related to potential user error in which it was suspected three batches of naturalyte were mixed improperly with the possibility of incorrect bicarbonate quantities.However, the retained sample of this batch of naturalyte was tested and all results were found to be within manufacturer specifications during manufacturer product investigation.Therefore, based on the information available, causality cannot be determined.Although a direct causal relationship could not be confirmed, a temporal relationship between the patient's hd treatment and the event of vomiting remains.Should additional new information be made available this clinical investigation will be reevaluated.
|