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Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Terumo Advanced Perfusion System 1

20 Jun 2014

Medical device manufacturer, Terumo, has issued a field safety notice concerning Advanced Perfusion System 1 with the following details:

  • Catalogue no.: 801763 (Base for Terumo Advanced Perfusion System 1, 100/120V); 801764 (Base for Terumo Advanced Perfusion System 1, 220/240V)
  • Serial no.: All
  • Dates of distribution: 23 Aug 2002 through current

Through internal assessment, the manufacturer has identified opportunities to improve patient safety by clarifying instructions in the Operators Manual for the Terumo Advanced Perfusion System 1. Updates to the Operators Manual will make the directions easier to follow and provide more accurate performance ranges that align with device operation.

The manufacturer is providing updated instructions to four sections of the Operators Manual, as the following addenda:

  • Terumo Advanced Perfusion System 1 Pressure Module
  • Terumo Advanced Perfusion System 1 Automatic Pump Direction Change
  • Terumo Advanced Perfusion System 1 Centrifugal Control Unit
  • Terumo Advanced Perfusion System 1 Modules

According to the local supplier, the affected products were not distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 20 Jun 2014

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