DISSOLUTION UNIT-TESTED

Additional Manufacturer Narrative

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

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 FRESENIUS DRY ACID MIXER WAS SEEN SMOKING AND GIVING OFF A BURNING SMELL DURING USE. UPON INSPECTION, THE BIOMED FOUND INTERIOR WIRING THAT WAS VISIBLY BURNED AND MELTED. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE WIRING WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BIOMED REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE BURNED AND MELTED WIRING. THE BIOMED CONFIRMED THAT THE DRY ACID MIXER WAS BEING REPLACED RATHER THAN BEING REPAIRED. THE DRY ACID MIXER WAS SCHEDULED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: ALTHOUGH IT WAS STATED THAT THE COMPLAINT DEVICE WAS AVAILABLE TO BE RETURNED, TO DATE 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.