DISSOLUTION UNIT-TESTED

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION WAS PERFORMED BY A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES). 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.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A BIOMEDICAL TECHNICIAN AT A USER FACILITY REPORTED A FRESENIUS DISSOLUTION UNIT WOULD NOT POWER ON. THE BIOMED CONFIRMED THAT WHILE SERVICING THE MACHINE, THEY TOUCHED THE CONTROL BOARD AND RECEIVED A SLIGHT ELECTRICAL SHOCK. THE BIOMED CONFIRMED THEY WERE NOT INJURED OR HARMED, AND CONFIRMED THEY DID NOT NEED ANY MEDICAL INTERVENTION AS A RESULT OF THE ISSUE. THE BIOMED CONFIRMED THERE WERE NO VISIBLE SPARKS OR ARCING, AND ADVISED THE CONTROL BOARD FUNCTIONED CORRECTLY AND DID NOT NEED TO BE REPLACED. THE BIOMED CONFIRMED THERE WAS NO ELECTRICAL ISSUE WITH THE MACHINE, AND CONFIRMED THEY REPLACED THE DISPLAY BOARD TO RESOLVE THE ORIGINAL NO POWER ISSUE AND RETURN THE MACHINE TO SERVICE.