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You are Here: Home Page > 1997 Press Releases > State Health Department Issues Report on Death at Hudson Valley Hospital  

State Health Department Issues Report on Death at Hudson Valley Hospital

Albany, June 17, 1997 – State Health Commissioner Barbara A. DeBuono, M.D., today released the State Health Department's report on the circumstances surrounding the death of a four–year old boy undergoing a adenoidectomy and myringotomy at Hudson Valley Hospital Center, in Peekskill.

The report, prepared after a four month investigation that involved numerous interviews, reviews of medical records and the advise and consultation of a practicing otolaryngologist, found that the most probable cause of the boy's death was an adverse reaction to the drug, phenylephrine, used to assist in hemostasis.

"Our investigators scrutinized a number of potential causes for this tragic death," said Dr. DeBuono. "Their findings, coupled with the failure of the child to react positively to resuscitation efforts, indicate an adverse reaction to the drug phenylephrine that produced massive vasoconstriction, acute heart failure and pulmonary edema."

As a result of the incident, and the report by Health Department investigators, Dr. DeBuono has issued an alert to New York State hospitals advising them of the circumstances of the case and has initiated a workgroup to study the use of the phenylephrine for this type of surgery and to develop recommendations and potential guidelines for the continued use of the drug during otolaryngology surgery. Recommendations from the workgroup are expected within 90 days with guidelines from the Health Department to follow shortly thereafter.

The Health Department's investigation began after the death of a four–year old boy, with a history of hearing loss and speech delay, who underwent an elective adenoidectomy and bilateral myringotomy and tube placement at Hudson Valley Hospital Center on February 7, 1997. During the course of the procedure, the boy suffered massive vasoconstriction and a hypertensive episode leading to cardiac arrest. After extensive CPR efforts at Hudson Valley, the boy was air transported to Westchester County Medical Center where resuscitation efforts continued. The boy expired at the Medical Center at 12 midnight the same day.

During the course of their investigation, Department investigators reviewed four potential causes of the patient's death. The potential causes were:

• An underlying cardiac condition in the patient. Although the patient had a history of a cardiac murmur noted in his pediatric record in 1994, investigators ruled this cause out because his pediatrician noted that during the next two years the murmur diminished and gradually disappeared. Additionally, no heart murmur was detected prior to surgery by the pediatrician, surgeon or anesthesiologist, and no evidence of underlying cardiac pathology was noted in the medical examiner's report.
• Operating Equipment Malfunction. Both the hospital and Department investigators reviewed this possibility. Written reports on equipment checks both prior to and subsequent to the procedure were reviewed and investigators scrutinized concerns by the surgeon that monitor alarms had been turned off. The post–procedure equipment checks and medical records indicated that this potential cause could be ruled out.
• Hypoxia caused by endotracheal tube misplacement or displacement.After extensive reviews by investigators and upon the advise and consultation of outside experts, this potential cause was ruled out. Although the operative procedure presented opportunities for the accidental dislodgement of the endotracheal tube, anesthesia monitoring equipment readings were normal throughout the procedure. This would not have been possible had there been even a brief period of extubation. In addition, the fact that the patient did not respond positively to rapid resuscitation efforts and was described by the surgeon as "ashen" –– not cyanotic or blue –– is consistent with overwhelming vasoconstriction.
• Adverse reaction to the intraoperative medications administered. Investigators found this to be the most likely cause of the patient's death. An almost instantaneous drop in blood oxygen levels, the patient's ashen color, and the failure of rapid resuscitation efforts, point to an unexpected adverse reaction from the phenylephrine administered to the patient, which produced massive vasoconstriction and hypertension, resulting in acute heart failure and pulmonary edema.

The Department's investigation found that the Hudson Valley Hospital Center took appropriate action in responding to this case. It fully complied with reporting and notification requirements, conducted its own quality assurance review and implemented policy changes to help prevent a similar occurrence in the future.

Because Department investigators found no action or omission on the part of the Hospital that would constitute a deviation from the acceptable standards of practice in this case, no deficiencies will be cited.

As part of the Health Department's alert concerning the use of phenylephrine, hospitals across the state will be asked to review their protocols and make appropriate adjustments to assure patient safety.

6/17/97–67 OPA