Death of 76-year-old woman from preventable medication error

30 times dose of Lepirudin

The plaintiffs decedent was a 76-year-old woman who died on 11/24/10 from a
hemorrhage. Her death occurred following a preventable medication error involving the
drug Lepirudin. The patient was given over 30 times too much medication which resulted
in uncontrollable internal bleeding and her subsequent death.
Her past medical history included cirrhosis with well preserved hepatocellular synthetic
function. She also had Type 2 diabetes, hypertension and hypercholesterolemia, and a
history of splenectomy for treatment of severe thrombocytopenia.
In August, 2010, she suffered a fall which led to a right humeral fracture. Her fracture
was to be managed conservatively. Following this injury, she remained hospitalized at
various facilities due to anemia, acute renal failure, urinary tract infections, and an upper
extremity blood clot. In November 2010, she was found to be suffering from Heparin
induced thrombocytopenia (HIT). It was noted that in light of her HIT, immediate
anticoagulation was necessary, and that Lepirudin would be administered. The order was
for 0.1 mg/kg/hr in a premixed continuous infusion. It was to be titrated to a PTT (waktu
dimana darah mulai membeku) level of 50-70. If the PTT was greater than 2.5 times the
baseline, then the infusion was to be held for two hours and reinstituted at 50% of the
original infusion dose. The PTT was then to be checked in 4 more hours. If the PTT was
less than 1.5 times the baseline, that the infusion rate was to be increased by 20% and
the PTT was to be rechecked. If in 4 hours the PTT was still subtherapeutic, the infusion
was to be increased by another 20%. The maximum dose to be administered was 16.5
mg/hr.
Lepirudin was started at 9:13 p.m. on 11/20/10. The initial dose was 7.2 mg/hr based
on the patients weight of 72 kg. Over the next several days, the Lepirudin dose was
altered in accordance with the physicians order as mentioned previously. At 6:00 a.m.
on 11/23/10, the Lepirudin was running at a rate of 0.5 mg/hr. At some point in the
morning, the nurse who reported understanding the intended dosing, made an error in
entering the information into the IV pump. A PTT level checked at 12:00 p.m. was
refused and was noted to be a compromised sample. The sample was not repeated by
the nurse or by any other provider at the time of the rejection.
At 3:25 p.m., due to miscommunication between nurses and doctors, the order for
Lepirudin was adjusted to run at the maximum dose of 16.5 mg/hr overnight on
11/23/10, and then was to be readjusted based on the diluted thrombin time dosing
guidelines.

The Lepirudin continued to infuse at the maximum dose over the course of that day. The
patient developed shoulder pain with movement, as well as hypotension and decreased
responsiveness. The Lepirudin was held as her hematocrit (HCT) was checked. She was
found to be profoundly anemic and was transfused. She was transferred to the Medical
Intensive Care Unit (MICU), where it was noted that she might have received too much
Lepirudin over the course of the day. There is no reversal agent for Lepirudin, and the
only available treatment was discontinuation of the drug, which had been discontinued
already. She continued to suffer from profound anemia and began oozing from all IV
sites. She passed away the following day from a hemorrhage.
The hospital prepared a Preventability Determination Narrative regarding the care
received and noted that the nurses note from the 11/22/10 night shift revealed the
Lepirudin dose of 0.5 mg/hr. It was initially thought that there had been a
misunderstanding of the dosage instructions at the time of the handoff from the night
nurse to the day nurse. Upon further discussion and interviews with the involved staff, it
was determined that the day nurse understood the intended dosing but made an error
when entering the dose into the IV pump.
The Root Cause Analysis revealed that documentation and communication of the dosing
of medication varied from the standard system of mg/kg/hr. The standard, pharmacy
approved dosing guideline for Lepirudin was followed until early in the morning of
11/23/10. Further, the blood specimen for the PTT taken at noon on 11/23/10 was
rejected as a compromised sample, and was not redrawn for some nine hours. It
appears that the compromised specimen was instead just a sample with no obtainable
clot. It was noted that the excessive medication dose was preventable and was a result
of a failure of systems within the hospitals control.
The plaintiff alleged that the doctors and nurses violated the standard of care when they
gave the patient an improper dose of medication, and failed to appreciate or correct the
error. As a direct result of the deviations from the accepted standard of care, the patient
suffered an excessive overdose of Lepirudin, directly leading to hemorrhage and death.
The defendants contended there was a systems error more than a failure of any one
individual. The defendants further contended that the patient was in dire medical
condition to begin with and may well not have survived the admission even if there had
been no medication error. Further, the defendants contended that the hemorrhage and
death may have been due to an underlying bleeding disorder unrelated to the medication
overdose.
The case was settled a month after the lawsuit was filed for $1,250,000.