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Summary of injuries incurred due to defective medical device: i endured over 30 days of chemotherapy during 5 years of fighting agent orange induced leukemia which resulted in veins in my arms becoming hardened, painful, and dangerous.Upon insistence from my nurses and doctors, i had a infusion port implanted subdural on (b)(6) 2011 by the same (b)(6) hospital where i was being treated.The port was a bard power port, lot: reuj0764, ref: (b)(4), serial#: (b)(6), made by bard access systems.It never worked correctly.It was defective in every way imaginable.The infusion technicians could not make it function properly and they refused to try to access it again after several failed attempts.It usually could not be accessed nor flushed and would not return blood but then when the access line was removed, it literally sprayed blood over the room.This bleeding was hard to stop resulting in repeated massive bruising and swelling around the port.The port was frequently blocked by clots.When accessed during treatments, the flow stopped frequently and almost always stopped when my body moved.The nurses referred to this as pinch off syndrome.This resulted in my iv alarm sounding constantly during treatments, causing great stress for me and all medical staff in my vicinity, and resulted in several uncompleted critical treatments.The catheter was obviously defective since it kinked in the middle of an essential and gentle curve resulting in 100% blockage which was confirmed by x-rays.Bard refused repeatedly to discuss this problem or offer any assistance.Their only response was to insist repeatedly that i return the port to them.That was an outrageous response by bard.Two of my doctors of oncology and several rns highly recommended my port be removed and stated it was defective and dangerous.After another traumatic experience with the port on (b)(6) 2011, the attending oncologist recommended an immediate test of the port by interventional radiology and stated my port was obviously totally defective and dangerous.Another oncologist wrote a recommendation to the surgical staff that my port must be removed immediately and within one week but a clerk (non medical staff person) for the surgical team, also in the same (b)(6) hospital, ignored that recommendation, downgraded the recommendation, and my many appeals for immediate treatment were ignored by the entire (b)(6) staff on (b)(6) 2011, my port had to be removed by a different non va surgeon at my expense.The surgeon who removed it stated in writing that he tested it and found a hole in the catheter at mid length.I have a copy of that report.I asked that surgeon if any of the many large iv bags of chemotherapy drugs which i received could be floating around in my chest cavity.He replied: you need to get an opinion on that.That recommendation caused great anxiety.I cannot determine what the possible medical consequences of the leakage and bleeding through that large hole are and might be in the future except that it is causing extreme mental anxiety and i am experiencing unusual and unprecedented abdominal pains, and sporadic bruising directly below where the port was implanted.This leakage from a medical device is clinically referred to as extravasation injuries.I have photos of these injuries.I asked the surgeon who implanted it, and bard, and my oncologist, and nurses, about possible symptoms and injuries caused by leakage but they all became defensive and nonresponsive.My last chemotherapy drug was relatively new to the va and fda.The catheter is discolored in the vicinity of the hole which indicates possible adverse reaction between my medicines and the catheter where the catheter was blocked and apparently leaked.My next crisis will be how to take future chemotherapy when required because, after this crisis.Having another port implanted would be extremely stressful.As of on (b)(6) 2012, my leukemia has reactivated ending hopes of remission.This recurrence could possibly be caused by the previously scheduled treatments which could not be completed due to the defective port.I established the chain of custody of this port and this port is physically in my possession.Bard denies any recalls but the fda and several bloggers report many recalls of related or the same bard product.Other bloggers have reported similar life threatening crises with bard power ports.I have a separate description of my personal injuries caused by this defective port.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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