Record number:
184
Adverse Occurrence type:
MPHO Type:
Time to detection:
immediately - 10 minutes
Alerting signals, symptoms, evidence of occurrence:
Flushing; pruritis; urticaria; wheezing; nausea; fever, vomiting, high or low blood pressure, chest pain, encephalopathy, stroke, and myocardial infarction following infusion of stem cells suspended in the cryopreservative DMSO, patient 1: total period of profound neurologic impairment was 12 hours; patient 2: acute neurologic symptoms lasted for less than 1 hour total.
Demonstration of imputability or root cause:
Large volume, high percentage of DMSO in the final product, not washed post thaw, patient sensitivity.
The authors conclude that DMSO toxicity - via diffuse vasospasm or another mechanism - may explain the patients' symptoms.
Imputability grade:
1 Possible
Keywords:
References:
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