Last update - 00:00 11/12/2006
Serious medical errors led to death of kidney donor at Beilinson
By Ran Reznick, Haaretz Correspondent
A series of serious medical errors led to the death of a live kidney donor shortly after the operation to remove the organ was carried out at Beilinson Hospital, Rabin Medical Center, Petah Tikva in September 2005, the Health Ministry committee of inquiry into the incident concluded. The report into the death of Oren Azaria was submitted recently to senior ministry officials.
The Beilinson transplant center, headed by Prof. Eitan Mor, is the largest in the country and is estimated to perform about 70 percent of all kidney transplants in Israel.
Azaria, a 38-year-old man from Ganei Tikva, donated his left kidney to a 44-year-old man from the center of the country. The transplant was successful, but Azaria died of abdominal bleeding about 11 hours after his surgery.
At the time, there were claims that Azaria was promised tens of thousands of dollars in exchange for donating the kidney, but Beilinson officials claimed Azaria's motivation was purely altruistic and that all the proper permits had been issued for the transplant. The committee did not investigate the case's ethical aspects.
According to the report, Azaria was operated on laparascopic, through a small abdominal incision, in the early morning hours. Four Hem-O-Lok clips, manufactured by the U.S. company Weck, were used. At first Azaria felt well and was returned to the ward in the afternoon, but at about 10 P.M. the on-call doctor who rushed to his room after hearing him shout found the patient unconscious and not breathing. Prof. Mor and senior department physician Dr. Natan Bar-Natan arrived while Azaria was being resuscitated.
At 11:30 P.M. Azaria was brought into surgery, during which large amounts of blood were found in his abdominal cavity. He was pronounced death sometime after midnight.
The committee determined that Azaria died of massive uncontrolled and untreated bleeding from an open renal artery as a result of the clips' having moved out of place. The committee noted that there had been previous cases (in the U.S., France and Singapore) of harm to patients caused by movement of the Hem-O-Lok clips. In addition, the committee said, in October 2001 a similar incident occurred in the U.S. hospital where Dr. Yoram Dekel, one of the surgeons who removed Azaria's kidney, did his medical residency, as a result of which the hospital banned the clip. In July 2006, the manufacturer issued a recall specifying that the clips should not be used for this type of operation.
According to the committee's report, use of the Hem-O-Lok clip was "a serious error by the surgical team" that "contributed to the massive bleeding and the patient's death." It concluded that despite the widespread use of the clip in laparascopic nephrectomies, the rare incidence of bleeding and the fact that the recall was issued only recently, "the surgeons should have taken extreme caution in their decision to use this clip and should not have relied on the manufacturer's guidelines."
The committee recommended that the Health Ministry prohibit the use of Hem-O-Lok clips for these operations and consider banning them outright for sealing off large arteries.
Regarding Azaria's death, the committee also concluded that the physicians who performed the resuscitation did not consider the possibility of abdominal bleeding and did not begin operating until it was too late to save his life.
Another finding was that Dr. Dekel was not informed of the complication immediately. He heard about it by chance and arrived only toward the end of the second operation. "Perhaps if he had been informed of the situation earlier, he would have raised the possibility of abdominal bleeding and rushed the patient into surgery," the report suggested.
The committee recommended that the transplant department require the immediate notification of surgeons in the event of significant complications. It also suggested that on-call ward physicians be retrained regarding the phenomenon of post-operative bleeding.
Officials at Beilinson said they have not yet obtained a copy of the committee's report and will issue a response once they have received it.