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Patient 1
CLINICAL INVESTIGATION: THERE IS A POSSIBLE TEMPORAL AND CAUSAL RELATIONSHIP BETWEEN THE ALLEGED INCORRECT MIXING OF THE GRANUFLO CONCENTRATE BY A NURSE AND THE DEATH OF THIS UNIDENTIFIED PATIENT DURING HEMODIALYSIS. HOWEVER, THERE IS NO ABILITY TO CONFIRM THE EVENT OR TO OBTAIN TREATMENT RECORDS FOR THE ALLEGED DEATH WITH GRANUFLO USE. THERE IS NO DOCUMENTATION IN THE COMPLAINT FILE OF AN EVENT DATE OR CLINIC LOCATION THAT THIS ALLEGED EVENT TOOK PLACE. THE ALLEGATION WAS IN A TWITTER SOCIAL MEDIA POST. THE GRANUFLO CONCENTRATE INSTRUCTIONS FOR USE (IFU) WARM ABOUT THE FAILURE TO FOLLOW THE INSTRUCTIONS PROPERLY AND THE POSSIBILITY OF PATIENT HARM IF NOT FOLLOWED. THE IFU GIVES INSTRUCTIONS FOR THE PROPER MIXING OF THE CONCENTRATE. BASED ON THE LIMITED INFORMATION AVAILABLE, IT CANNOT BE DETERMINED IF THE USE OF THE ALLEGED INCORRECTLY MIXED GRANUFLO CONCENTRATE CAUSED OR CONTRIBUTED TO ANY PATIENT ADVERSE EVENT. PLANT INVESTIGATION: PLANT INVESTIGATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE SERIAL NUMBER COULD NOT BE OBTAINED. AS A SERIAL NUMBER COULD NOT BE DETERMINED, DEVICE HISTORY AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.