GRANUFLO DISSOLUTION TANK

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A MIX MOTOR STARTED SMOKING DURING TRANSFER OF CONCENTRATE AND REQUESTED FOR THE PART NUMBER OF THE MIX MOTOR. THE BMT STATED THE BUILDING WAS FILLING WITH SMOKE AND WAS NEARLY EVACUATED. TECHNICAL SUPPORT PROVIDED THE PART NUMBER. UPON FOLLOW-UP, THE BMT STATED PREVENTATIVE MAINTENANCE WAS PERFORMED AND THE MIXER WAS RETURNED TO SERVICE WITHOUT FURTHER ISSUE. IT WAS REPORTED THE REPLACED COMPONENT WAS DISCARDED AND WAS NO LONGER AVAILABLE FOR INVESTIGATION. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED.

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 USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A MIX MOTOR STARTED SMOKING DURING TRANSFER OF CONCENTRATE AND REQUESTED FOR THE PART NUMBER OF THE MIX MOTOR. THE BMT STATED THE BUILDING WAS FILLING WITH SMOKE AND WAS NEARLY EVACUATED. TECHNICAL SUPPORT PROVIDED THE PART NUMBER. UPON FOLLOW-UP, THE BMT STATED THE BUILDING WAS FILLING WITH SMOKE AND WAS NEARLY EVACUATED. THE BMT STATED NO FLAME OR ARCING, OR ANY OTHER VISIBLE HEAT DAMAGE RELATED TO THE SMOKE WAS OBSERVED ON THE MIX MOTOR. THE BMT STATED THE MIX MOTOR WAS THE ORIGINAL FRESENIUS PART ON THE MIXER. THE BMT STATED PREVENTATIVE MAINTENANCE WAS PERFORMED AND THE MIXER WAS RETURNED TO SERVICE WITHOUT FURTHER ISSUE. ADDITIONALLY, THE BMT CONFIRMED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES. THE BMT CONFIRMED THERE WAS NO PATIENT INVOLVEMENT OR HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. IT WAS REPORTED THE REPLACED COMPONENT WAS DISCARDED AND WAS NO LONGER AVAILABLE FOR INVESTIGATION.

Additional Manufacturer Narrative

CORRECTION: FOLLOW-UP #1 SUBMISSION IS A CORRECTION FOR B5 AND NOT ¿ADDITIONAL INFORMATION¿ THAT WAS MADE AWARE/REALIZED ON 07/21/2022, AND NOT 06/28/2022 AS ORIGINALLY REPORTED.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A MIX MOTOR STARTED SMOKING DURING TRANSFER OF CONCENTRATE AND REQUESTED FOR THE PART NUMBER OF THE MIX MOTOR. THE BMT STATED THE BUILDING WAS FILLING WITH SMOKE AND WAS NEARLY EVACUATED. TECHNICAL SUPPORT PROVIDED THE PART NUMBER. UPON FOLLOW-UP, THE BMT STATED THE BUILDING WAS FILLING WITH SMOKE AND WAS NEARLY EVACUATED. THE BMT STATED NO FLAME OR ARCING, OR ANY OTHER VISIBLE HEAT DAMAGE RELATED TO THE SMOKE WAS OBSERVED ON THE MIX MOTOR. THE BMT STATED THE MIX MOTOR WAS THE ORIGINAL FRESENIUS PART ON THE MIXER. THE BMT STATED PREVENTATIVE MAINTENANCE WAS PERFORMED AND THE MIXER WAS RETURNED TO SERVICE WITHOUT FURTHER ISSUE. ADDITIONALLY, THE BMT CONFIRMED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES. THE BMT CONFIRMED THERE WAS NO PATIENT INVOLVEMENT OR HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. IT WAS REPORTED THE REPLACED COMPONENT WAS DISCARDED AND WAS NO LONGER AVAILABLE FOR INVESTIGATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE COMPONENT WAS NOT RETURNED; A PHYSICAL INVESTIGATION WAS NOT PERFORMED. INVESTIGATION DETERMINES THAT THERE WAS CAUSAL RELATIONSHIP BETWEEN THE OBJECTIVE EVIDENCE AND THE ALLEGED EVENT; THE ALLEGED EVENT IS CONFIRMED. 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.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A MIX MOTOR STARTED SMOKING DURING TRANSFER OF CONCENTRATE AND REQUESTED FOR THE PART NUMBER OF THE MIX MOTOR. THE BMT STATED THE BUILDING WAS FILLING WITH SMOKE AND WAS NEARLY EVACUATED. TECHNICAL SUPPORT PROVIDED THE PART NUMBER. UPON FOLLOW-UP, THE BMT STATED THE BUILDING WAS FILLING WITH SMOKE AND WAS NEARLY EVACUATED. THE BMT STATED NO FLAME OR ARCING, OR ANY OTHER VISIBLE HEAT DAMAGE RELATED TO THE SMOKE WAS OBSERVED ON THE MIX MOTOR. THE BMT STATED THE MIX MOTOR WAS THE ORIGINAL FRESENIUS PART ON THE MIXER. THE BMT STATED PREVENTATIVE MAINTENANCE WAS PERFORMED AND THE MIXER WAS RETURNED TO SERVICE WITHOUT FURTHER ISSUE. ADDITIONALLY, THE BMT CONFIRMED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES. THE BMT CONFIRMED THERE WAS NO PATIENT INVOLVEMENT OR HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. IT WAS REPORTED THE REPLACED COMPONENT WAS DISCARDED AND WAS NO LONGER AVAILABLE FOR INVESTIGATION.