Zevex International, 4/11

Zevex International, 4/11

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Warning Letter noting inadequate validation of changes to infusion pump software.

Description

 

  • Zevex International, 4/11

    This Warning Letter includes an observation regarding an infusion pump that had undergone several software revisions in an attempt to eliminate problem. These revisions were not adequately validated. The infusion pumps continued to experience problems. No documentation was provided to ensure that the validation of the software was conducted at every change to include compatibility with previously released software and servicing requirements. Additionally, the version of the software had been developed to address the issue. However, there was no documentation submitted to FDA for the ongoing validation that was being conducted.

    pa document category Warning Letter
    Regulation Category Devices – GMP
    FDA Office Denver District
    System Category Medical Device
    Citation Category Validation

 

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