MAHURKAR

Description of Event or Problem

ACCORDING TO THE REPORTER, THE PATIENT WITH UREMIA UNDERWENT PLACEMENT OF A TEMPORARY INGUINAL CHRONIC CARBOTHANE CATHETER FOR HEMODIALYSIS ON (B)(6). FOLLOWING CATHETER INSERTION, REGULAR HEMODIALYSIS WAS INITIATED. ON (B)(6), THE PATIENT DEVELOPED FEVER AND CHILLS, WITH A MAXIMUM BODY TEMPERATURE OF 39.5°C. PHYSICAL EXAMINATION REVEALED COARSE BREATH SOUNDS IN BOTH LUNGS WITHOUT OBVIOUSLY OR MOIST RALES. A SMALL AMOUNT OF PURULENT FLUID WAS OBSERVED AT THE INGUINAL CATHETER SITE. AUXILIARY TESTS SHOWED ON (B)(6) AT 08:18 THAT THE WHITE BLOOD CELL COUNT WAS 13.86×10^9/L, THE NEUTROPHIL PERCENTAGE WAS 91.8%, AND THE PROCALCITONIN WAS 0.18 NG/ML, SUGGESTING A POSSIBLE CATHETER-RELATED INFECTION. THE CATHETER WAS REMOVED, AND PURULENT FLUID WAS SENT FOR BLOOD CULTURE, WHICH GREW STAPHYLOCOCCUS AUREUS. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A REMEDIAL ACTION, THE PATIENT WAS TREATED WITH INTRAVENOUS CEFOPERAZONE-SULBACTAM FOR INFECTION, ALONG WITH PHYSICAL COOLING MEASURES. HOWEVER, THE CATHETER WAS NOT REPLACED, AND THE PROCEDURE WAS NOT COMPLETED. BY AUGUST 13, THE PATIENT'S BODY TEMPERATURE NORMALIZED TO 36.5°C, THE WHITE BLOOD CELL COUNT DECREASED TO 7.50×10^9/L, AND THE NEUTROPHIL PERCENTAGE WAS 61.4%. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED.

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.