Description of Event or Problem · 1
I AM WRITING TO INFORM YOU OF A POTENTIAL PROBLEM WITH AN IMPLANTABLE XCELA POWER INJECTABLE PORT. I ATTEMPTED TO USE THE ONLINE REPORTING FORM BUT IT WAS NOT OPERATING PROPERLY. I ATTEMPTED TO CONTACT THE MANUFACTURER, NAVILYST MEDICAL INC ON THEIR WEBSITE BUT HAVE RECEIVED NO RESPONSE. ON (B)(6) 2013, PATIENT (B)(6) HAD A PORT INSERTED UNDER THE RIGHT CLAVICLE FOR USE IN TREATING MULTIPLE MYELOMA. THE INSERTION WAS DONE BY DR (B)(6), AN INTERVENTIONAL RADIOLOGIST AT (B)(6). THE (B)(6) PATIENT WAS PREVIOUSLY HEALTHY AND WAS DIAGNOSED WITH THE CANCER IN (B)(6) 2012. HE HAS HAD NO CHEMOTHERAPY YET. TWO DAYS AFTER IMPLANTATION OF THE PORT, THE AREA BECAME VERY RED, SWOLLEN AND TENDER. THE PATIENT HAD RECEIVED IV INFUSIONS (NOT CHEMOTHERAPY) THROUGH THE PORT ON (B)(6). THE PATIENT DEVELOPED SEVERE CHILLS AND WAS ADMITTED TO (B)(6) ON (B)(6) FOR A PRESUMPTIVE CENTRAL LINE INFECTION. ROCEPHIN AND VANCOMYCIN WERE GIVEN BY PERIPHERAL IV. THE PORT WAS REMOVED THE FOLLOWING DAY. NO MENTION OF A HOLE IN THE CATHETER OR OTHER ABNORMALITY OF THE PORT WAS NOTED BY DR (B)(6), THE IR PHYSICIAN WHO REMOVED THE PORT. THE AREA AROUND THE PORT WAS NOTED TO HAVE FLUID IN THE TISSUE BUT NO PUS. A BLOOD CULTURE AND CULTURE OF THE LINE TIP WERE BOTH NEGATIVE. IT APPEARS THAT THE PORT WAS NOT INFECTED BUT RATHER LEAKED INTO THE TISSUE. IT IS NOT POSSIBLE TO SAY WHETHER THIS WAS DUE TO IMPROPER INSERTION OR FAILURE OF THE DEVICE. THE PORT WAS NOT SAVED FOR ANALYSIS OF ANY DEFECT. I AM SENDING THIS REPORT IN CASE THIS PARTICULAR PORT IS LIKELY TO FAIL IN THIS FASHION. THE PORT WAS A 9.6F CATHETER AND LOT NUMBER 121332 000 AND (B)(4).