DISSOLUTION UNIT-TESTED

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 (BIOMED) AT A USER FACILITY REPORTED THAT A DISSOLUTION MIX MOTOR WOULD NOT TURN ON AND WAS SMOKING. THERE WAS NO VISIBLE HEAT DAMAGE FOUND ON THE MACHINE, AND THE SMOKE WAS VISUALLY CONFIRMED COMING FROM THE MACHINE BY STAFF. THE BIOMED CONFIRMED THE ISSUE OCCURRED DURING USE WHILE MIXING. THE BIOMED CONFIRMED THAT THEY REPLACED THE MIXER MOTOR TO RESOLVE THE ISSUE AND RETURNED THE MACHINE TO SERVICE, AND CONFIRMED THAT THE MIXER MOTOR WAS THE ORIGINAL PART ON THE MACHINE. THE BIOMED CONFIRMED THE MACHINE HAD NOT HAD PRIOR ELECTRICAL ISSUES, AND CONFIRMED IT WAS PLUGGED INTO A HOSPITAL GRADE GFI OUTLET. THE BIOMED CONFIRMED THERE WAS NO OTHER DAMAGE TO THE MACHINE THERE WAS NO PATIENT INVOLVEMENT. NO PARTS WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

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.