inforMED
MalfunctionJRO

GRANUFLO DISSOLUTION TANK

Received Aug 8, 2019 · Event occurred Jul 30, 2019

Report 2937457-2019-02466 · MDR key 8874980

Device

Generic name

Blender/mixer

Catalog number

RTLG047-80101

Lot number

N/A

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 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 (BIOMED) AT A USER FACILITY REPORTED THAT A DRY ACID MIXER PUMP WAS BURNED DUE TO OVER RUNNING. THE BIOMED STATED THAT THE PUMP WILL RUN FOR ABOUT 8 SECONDS THEN SHUTS OFF AND HAS TO BE RESTARTED. THE BIOMED STATED THERE WAS NO PATIENT INVOLVEMENT. THE BIOMED NOTICED SMOKE AND A BURNED COMPONENT, HOWEVER THERE WAS NO SPARK, FLAME OR BURNING SMELL. THE BIOMED STATED THAT THE SENSOR ON THE PUMP WAS FAULTY WHICH LED TO THE DRY ACID MIXER PUMP OVER RUNNING. THE SENSOR WAS REPLACED, AND THE MACHINE IS BACK IN SERVICE. THE BIOMED REPORTED THAT THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE MACHINE IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BIOMED WAS UNABLE TO PROVIDE THE APPROXIMATE HOURS OF THE MACHINE BUT STATED THAT THE MACHINE IS VERY OLD. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION