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Living Donor Risks Living Kidney Donor OPTN

Second Living Kidney Donor Death in 2015

This one occurred last month at UCSF. Little details are known at this time, but the program has been halted temporarily (standard procedure).

Earlier this year, don’t forget, Jamie Donaldson died at Gulf Coast Medical Center.

This makes TWO living kidney donors deaths (within 30 days of surgery) in 2014 and TWO in 2015….. That the public and media knows about, that is.

Why so cynical, you ask?

 

Well, the first articles that emerged about this living donor’s death said:

“According to the Organ Procurement and Transplant Network (OPTN), from 2009-13, four living kidney donor deaths due to medical causes were reported nationwide within the first 30 days of donation, none of which occurred at UCSF.”

 

Read that again: Between 2009-2013

4 kidney donor deaths in 5 years sounds a hell of a lot better than 8 deaths in 7 years, doesn’t it?

More details as I get ’em.

 

Categories
Living Donor Risks Living Kidney Donor

More on Kidney Donor Jamie Donaldson’s Death

On April 16, 2015, Jamie Donaldson died while donating a kidney to his father, Frank Donaldson, at Gulf Coast Medical Center in Fort Myers, Florida. Per federal guidelines, Gulf Coast’s transplant services were suspended until an investigation is complete.

Liz Freeman, of the Naples Daily News, has been covering this story from the beginning. Below is her latest contribution. The original article can be found here. It, unfortunately, requires one to be a subscriber to see the whole thing. Transcription below.

 

Man who donated kidney to dad died from internal bleeding, autopsy shows

 

John “Jamie” Donaldson bled to death after donating a kidney to his ailing father at Gulf Coast Medical Center this past spring, according to an autopsy report released Wednesday.

The excessive bleeding was due to failure of a clamp or staple that should have sealed the renal artery stump after the left kidney was removed for the transplant, according to the Lee County Medical Examiner’s Office.

In addition, there was a small cut to the aorta just below the left renal artery but it had been closed by a metallic staple, the report said. The medical examiner said the death was accidental.

The autopsy for the 40-year-old Cape Coral resident sheds light on what went wrong during the April 16 living kidney transplant surgery at Gulf Coast. Donaldson’s death led the hospital to voluntarily halt all kidney transplants involving living donors while a probe was conducted.

Donaldson was donating a kidney to his 69-year-old father, Frank Donaldson, also of Cape Coral, who learned of his son’s death after waking up in the recovery room.

The suspension of transplants for living kidney donations took effect April 21 and is still in place. Other patients and their living donors are in waiting mode or transferring to other transplant programs.

The United Network for Organ Sharing, which operates the nation’s transplant program under contract with the federal government, was notified. The U.S. Department of Health and Human Services, which contracts with UNOS, also has been informed.

Lee Memorial Health System, which runs Gulf Coast, issued a statement Wednesday:

“The autopsy supports our initial assessment that the patient experienced excessive bleeding, which is a rare, but known complication,” hospital spokeswoman Mary Briggs said. “All potential kidney donors go through an extensive medical clearance process, which includes a comprehensive medical and psychosocial evaluation to determine if they are suitable for organ donation. After undergoing this extensive evaluation, Mr. Donaldson was cleared for the kidney donation.

“Our deepest sympathies are with the Donaldson family during this difficult time and to our extraordinary caregivers who are dedicated to healing patients even in the most trying circumstances.”

Frank Donaldson said Wednesday he had not seen the autopsy report.

“I haven’t dealt with Jamie’s situation yet,” he said, using his son’s nickname. “I want to heal myself. Eventually I will. Until then, I have to get myself in decent shape.”

His son’s death after he received a new life without dialysis is not a good feeling, he said.

“No father should bury their child before him,” he said. “No matter what I do, it isn’t going to bring Jamie back.”

The transplant went well and Frank Donaldson goes weekly to his kidney specialists for progress checks, from blood work to adjustments for anti-rejection medications, he said.

The hospital reached out to him early after the transplant but not recently, and he has not spoken with the transplant surgeon. He isn’t surprised by that.

“I’m a tough old dude. I’ve been around a long time. I am pretty patient waiting for someone to talk to us,” he said. “Sometimes a one-on-one can save a lot of grief and costs in court.”

There’s another issue, he said, and that’s the $1 million life insurance policy he paid for in his son’s name in case something went wrong. His son’s wife, Christine Donaldson, is the beneficiary.

The life insurance company sent her a letter refusing to pay the claim, Donaldson said. She is having to deal with that issue now, along with how her three children are coping with the loss of their father, he said.

Categories
Advocacy Ethical Considerations Living Donor Protections Living Donor Risks Living Kidney Donor OPTN Psychosocial Risks

Living Donor Dies at Erie County Medical Center

Here are the facts:

ECMC is suspending its living kidney transplant program following the death of a donor from an illegal drug overdose.

Doctors successfully transplanted the organ to a family member in the spring of 2013. Six months later, the donor died.

ECMC decided, with consultation with the United Network for Organ Sharing, the non-profit organization that regulates live organ donations, to temporarily suspend the program until mid-July 2014.

The hospital released the following statement:

“ECMC proactively decided to temporarily suspend living donor recoveries. The ECMC transplant program otherwise continues unaffected and ECMC fully expects that the living donor program will be reinstated by mid-July 2014. In the meantime, the transplant program will fully support and guide any potential living organ donor and recipient in the alternatives available to them.”

 

If that were the end of it, this would be a short post. But it’s not. At least two news stations, WIVB and WGRZ, managed to make this tragedy all about the recipients. Here is the missive I sent to both these reporters (the version below went to Brown at WGRZ; I altered the wording regarding Laurie and Chase for Ms. Kingston):

 

As a living kidney donor and living donor activist, I read the news of ECMC’s living donor death with great sadness. My sorrow, however, became dismay when I realized your story’s only concern was the temporary cessation of transplants. As if the donor’s death were nothing more than an afterthought.

The first living kidney donor transplant occurred in 1954, yet a psycho-social evaluation was not required for potential living donors until 2007 (CMS Final Rule). But it wasn’t until last year, under pressure from HRSA at DHHS, that the policy specified details.

Currently, a transplant center must obtain the prospective living donor’s history of “smoking, alcohol, and drug use, abuse, and dependency”.

They must also screen for “any psychosocial issues, including mental health issues that might complicate the living donor’s recovery and could be identified as potential risks for poor psychosocial outcome”.

And finally, a transplant center is supposed to exclude or reject any potential living donor with a “diagnosable psychiatric condition requiring treatment before donation, including any evidence of suicidality”.

But here’s the reality:

  • Approximately, 30% of U.S. living donors experience depression, anxiety, anger, grief and/or PTSD post-donation.
  • One-third of living kidney donors’ psychological and distress scores worsened one and three months following donation. (Taghavi 2001).
  • 15% of kidney donors are on antidepressants three months after donation (McCune)
  • 2% of donors had a Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) psychiatric diagnosis preoperatively, however, 15% had an Axis I disorder at 12 months. (Smith et. al. 2004).

All of these findings well exceed the community sample range of 2 to 9% for major depression as reported in the DSM-IV.

Transplant centers are not specifically required to offer structured aftercare or support services to living donors, and in fact, not a single center does. Yet it’s been determined by multiple studies that a lack of support contributes to these issues, and early counseling may alleviate suffering.

ECMC determined this living donor to be healthy, both physically *and* psychologically. Yet six months later, s/he is dead. This is a patient safety failure of massive proportions. Instead of lamenting the delay, Laurie and Chase should be grateful; this investigation just might save her life.

Because after all, we’re more than medical supply. Living donors are people too.

 

Note: In 2007, OPTN’s Living Donor Committee proposed comprehensive standards for living donor evaluation, selection and treatment. These policies were violently rejected by the “membership” (aka the transplant centers). I bring it up because the proposed policy contained an appendix with a detailed rationale for interviewing a “Donor Support Person” (spouse, significant other, parent, friend, etc) during the living donor evaluation AND an inventory of questions for a POST-donation psychosocial interview of the living donor.

Categories
Living Donor Risks Living Kidney Donor

Kidney Donor Dies Because Surgeons Don’t Read Warning Letter

And yet another death from the Hemolock clip:

Kidney-donor deaths linked to surgical clips raise issues of alerts, warnings
Surgeons at University Medical Center in Lubbock, Texas, rushed Florinda Gotcher back into the operating room. Once they opened her up again, they saw something horrible had happened: there was a pool of blood in her abdomen. Gotcher, 41 and the mother of four, had died from a massive and sudden bleed.

Melinda Williams pays tribute at the grave of her mother, Floridna Gotcher.
“My world just fell apart and my heart was torn to pieces,” Williams says of her mother’s sudden death.”They told us, ‘We couldn’t save her. Sorry, we did everything we possibly could, but there’s nothing we could do.'”

 

Which, of course, was a lie. They could’ve used the right surgical equipment.

 

I’ve talked about the hemolock clip in prior posts. Review if you want a refresher.

Categories
Living Donor Protections Living Donor Risks

Proof That Some Kidney Donor Deaths Are Completely Preventable

I tweeted this article when it was first printed a couple of days ago, but I wanted to make a few comments about it here.

In short, a number of living kidney donors died because surgeons used a blood vessel clip they knew was prone to failure. So prone to failure that the FDA issued a temporary ban on the clip in 2006, after three LKDs died.

Oh and by the way, there have also been “several” other cases where living kidney donors have suffered major hemorrhages because of this damned clip too.

Living kidney donors endure a needless medical procedure, relinquish a major organ then spend their lives in a permanently compromised state all because they want to help another person (and that’s if things go well. there’s always the possibility of major complications, psychosocial problems and financial drains). Yet the transplant surgeons can’t care enough to heed data and federal notices that say, “Hey, don’t use this clip on a living donor nephrectomy because you cut the renal stump too short. This causes clip failure, resulting in major bleeding and death”.

They do this why – because clips are cheaper; because their personal opinion is that it’s not dangerous because they’ve never killed anyone (yet)? The arrogance and lack of empathy is infuriating.

And the article climaxes on one of my favorite transplant industry-related pet peeves: the hording/hiding of information by UNOS/OPTN, CMS (medicare) and the FDA on deaths and complications.

Dr. Friedman contended that these regulatory agencies have balked at releasing case details out of medicolegal concerns about discoverability and confidentiality.

“discoverability” = it’s more important to help the hospitals, transplant programs and surgeons to cover their asses from a much-deserved lawsuit than it is to protect the public.

And folks wonder why I’m so angry.

 

ETA: May 2011 FDA and HRSA warning on the use of these clips on living kidney donors.

ETA 6-9-2012: http://www.pharma-watch.com/fda-alerts/weck-hem-o-lok-ligating-clips.html

ETA 4-1-2015: Click in the article no longer works. A search on the website provided this: http://www.ehospitalistnews.com/?id=760&tx_ttnews[tt_news]=56613&cHash=eda7b64ec49534e8e5b8571474eddb4d