AUTOLOG IQ

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT THERE WAS A SUCTION FAILURE. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. AN ADVERSE PATIENT EFFECT WAS REPORTED, BUT THE SPECIFIC OUTCOME WAS NOT PROVIDED. THE EVENT DID NOT RESULT IN A DELAY OF THE PROCEDURE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CELL SAVER WAS ASKED TO BE SET UP FOR THE CASE AS PATIENT WAS A JEHOVAH'S WITNESS AND REFUSING BLOOD PRODUCTS, AND DUE TO THE PROXIMITY OF THE PULMONARY VEINS TO THE ESOPHAGEAL TUMOR. AS SURGERY PROCEEDED, A LARGE AMOUNT OF BLEEDING WAS NOTED QUICKLY, UNABLE TO CONTROL WITH FINGER PRESSURE; CHEST PACKED WITH LAPAROTOMY SPONGES AND HELP CALLED FROM ON-CALL VASCULAR SURGEON AND THORACICS. BLOOD LOSS WAS SIGNIFICANT, CELL SAVER BLOOD GIVEN TO PATIENT AS IT BECAME AVAILABLE, BUT MORE BLOOD LOSS CAME ABOUT AS AN INJURY TO THE UNDERSURFACE OF THE AORTIC ARCH WAS DISCOVERED. PATIENT HAD CHEST COMPRESSIONS, SEVERAL ROUNDS OF INTERNAL PADDLE DEFIBRILLATION, FLUID RESUSCITATION, EPINEPHRINE AND CELL SAVER BLOOD, AND DID NOT REGAIN VITAL SIGNS. THERE WAS 5000 ML OF BLOOD ESTIMATED LOSS. EARLY INTO THE COLLECTION OF BLOOD, THE SURGERY TEAM NOTED THAT THE SUCTION WAS QUITE WEAK/SLOW. HALFWAY THROUGH THE COLLECTION OF BLOOD WITH AUTOLOG IQ, SUCTION HAD ENTIRELY STOPPED WORKING AND IT WAS NOTED THAT THE BACK TRAP HAD BEEN BACKFILLED WITH BLOOD AND CLOGGED. ATTEMPTS WERE MADE TO CLEAN OUT THE SUCTION TRAP TO NO SUCCESS, A BACKUP NON-MEDTRONIC CELL SAVER ELITE AND UNIT HAD TO BE SET UP AND BLOOD COLLECTION CONTINUED VIA THIS UNIT.

Additional Manufacturer Narrative

DEVICE EVALUATION SUMMARY: THE REPORTED SUCTION FAILURE ISSUE WAS VERIFIED DURING PRELIMINARY ANALYSIS. SERVICE TECHNICIAN STATED THAT THE INSTRUMENT DID NOT PASS PREVENTIVE MAINTENANCE DUE TO DETECTOR FAILURE AND VACUUM DECAY FAILURE. THE ISSUE WILL BE RESOLVED BY REPLACING THE DETECTOR. SERVICE TECHNICIAN ALSO OBSERVED SMALL PIECES OF DRIED BLOOD WERE OBSERVED DURING THE CENTRIFUGE CLEANING PROCESS. THE UNIT WILL BE RETURNED FOR FURTHER INVESTIGATION AND EVALUATION. SERVICE WAS NOT COMPLETED AT THIS TIME. 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.