CARPEDIEM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. ONE DISPLAY COMPONENT WAS RETURNED, SEALED IN APPROPRIATE PACKAGING. VISUAL INSPECTION NOTED NO VISIBLE DAMAGE TO ANY COMPONENTS OF THE MACHINE SYSTEM, INCLUDING THE LIQUID CRYSTAL DISPLAY (LCD) DISPLAY, INTERFACE DISPLAY BOARD, AND INVERTER BOARD. WHEN THE DEFECTIVE DISPLAY WAS CONNECTED TO THE MACHINE FOR TESTING, THE SCREEN REMAINED COMPLETELY BLACK. THE MACHINE WAS BUILT WITH SELF-EXTINGUISHING MATERIALS. IT WAS REPORTED THAT THERE WAS A MONITOR PROBLEM AND SMOKE. THE REPORTED ISSUES WERE CONFIRMED. THE MOST LIKELY CAUSE WAS DUE TO A FAILURE OF THE DISPLAY COMPONENT, CAUSED BY A DAMAGED CONNECTION TO THE COLD CATHODE FLUORESCENT LAMP (CCFL). IN THE EVENT OF AN ELECTRONIC FAILURE, A BURNING SMELL OR SMOKE CAN BE EMITTED FROM THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING CVVHD (CONTINUOUS VENO-VENOUS HEMOFILTRATION AND DIALYSIS) TREATMENT, THE MACHINE'S DISPLAY WENT B LACK, AND THE CUSTOMER REPORTED A BURNING SMELL. NO ALARMS WERE ACTIVATED. THERE WERE NO LABELING AND PACKAGING ISSUES. THE EVENT WAS NOT CONSIDERED LIFE-THREATENING. THERE WAS NO MEDICAL INTERVENTION REQUIRED TO PREVENT PERMANENT HARM OR DEATH. THE TREATMENT WAS INTERRUPTED DUE TO THE EVENT, AND THE BLOOD WAS SUCCESSFULLY RETURNED TO THE PATIENT. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSIONS PERFORMED. THE EVENT DID NOT RESULT IN ANY IMPACT TO THE PATIENT, AND THERE WAS NO REPORTED PATIENT INJURY.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING CVVHD (CONTINUOUS VENO-VENOUS HEMOFILTRATION AND DIALYSIS) TREATMENT, THE MACHINE'S DISPLAY WENT BLACK, AND THE CUSTOMER REPORTED A BURNING SMELL. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO ALARMS WERE ACTIVATED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE EVENT WAS NOT CONSIDERED LIFE-THREATENING. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE TREATMENT WAS INTERRUPTED DUE TO THE EVENT, AND THE BLOOD WAS SUCCESSFULLY RETURNED TO THE PATIENT. AS A REMEDIAL ACTION, THE MACHINE WAS TURNED OFF AND PULLED OUT OF SERVICE BY THE CUSTOMER, AND A SERVICE TICKET WAS OPENED FOR REPAIR. THE TREATMENT DID NOT CONTINUE, AND THE TREATMENT WAS NOT COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS PERFORMED. THERE WAS NO MEDICAL INTERVENTION REQUIRED TO PREVENT PERMANENT HARM OR DEATH. THE EVENT DID NOT RESULT IN ANY IMPACT TO THE PATIENT, AND THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, G3. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.