DISSOLUTION UNIT-TESTED
Received Dec 5, 2019 · Event occurred Nov 18, 2019
Report 2937457-2019-03532 · MDR key 9418172
Device
Product problems
- Thermal Decomposition of Device
- Smoking
- Thermal Decomposition of Device
- Smoking
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
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 FIELD SERVICE TECHNICIAN (FST). 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 (BIOMED) AT A USER FACILITY REPORTED THAT THE MIXER MOTOR ON A GRANUFLO DRY ACID MIXER WAS ACCIDENTALLY SPRAYED WITH WATER WHEN THE STAFF WAS CLEANING THE MACHINE. THIS CAUSED A SHORT IN THE MIXER MOTOR AND TRIGGERED A BURNING SMELL ALONG WITH SMOKE, WHICH APPEARED TO BE COMING FROM THE MOTOR. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THE BIOMED STATED THERE WERE NO SPARKS, FLAMES, OR ARCING NOTED, AND NO MELTED PARTS WERE FOUND. WHILE INSPECTING THE MACHINE, THE BIOMED NOTED THAT THE TERMINAL CONNECTIONS ON THE MIXER WERE SLIGHTLY BLACKENED (OR CHARRED). IT WAS CONFIRMED THAT THE MIXER WAS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE MACHINE IS ABOUT THREE YEARS OLD. THERE WAS NO OTHER DAMAGE REPORTED. THE BIOMED REPLACED THE MIXER MOTOR TO RESOLVE THE REPORTED ISSUE. THE MACHINE HAS BEEN RETURNED TO SERVICE AND WAS REPORTED TO BE FULLY OPERATIONAL. NO SAMPLE AVAILABLE FOR PHYSICAL EVALUATION; THE MIXER MOTOR REPLACED BY THE BIOMED WAS DISCARDED.