Terumo Advanced Perfusion System 1 (ABD Module or Occluder Module… — recall 48252
Health Canada — Medical Devices · Canada · 2013-01-07 · Type II
As described by Health Canada — Medical Devices: Terumo Advanced Perfusion System 1 (ABD Module or Occluder Module Malfunction)
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Archived by the issuing authority — kept for reference
Reported risk: Terumo CVS initially received nine reports of malfunction of the ABD module or the occluder module for the Terumo Advanced Perfusion System 1. Its investigation found a faulty component on the modules application board had caused the failures. Terumo CVS replaced all modules in the affected population. Terumo CVS has subsequently received two additional reports of similar malfunctions. The ensuing investigation concluded that, though highly unlikely, it is possible for the same component to fail in any module.
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