Bacterial contamination during collection, processing, cryopreservation, or thawing

Record number: 
178
MPHO Type: 
Alerting signals, symptoms, evidence of occurrence: 
Sterility testing at various points from collection to pre-infusion
Demonstration of imputability or root cause: 
Routine microbiological assays of 3078 infused hematopoietic progenitor cell (HPC) products for autologous and allogeneic transplantation. Thirty-seven (1.2%) contaminated products were found. All patients receiving contaminated infusions. received empirical antibiotic prophylaxis according to the assay result. None of these patients developed a positive blood culture with the same agent.