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Problem Management Scenario # 1

Problem Management Scenario # 1. September 17,2005. Scenario # 1. Bags R Us has issued a voluntary recall of their Cryorific ™ freezing bags due to a problem with their sterilization validation. What do you do?. General Investigational Approach.

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Problem Management Scenario # 1

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  1. Problem Management Scenario # 1 September 17,2005

  2. Scenario # 1 • Bags R Us has issued a voluntary recall of their Cryorific™ freezing bags due to a problem with their sterilization validation. • What do you do?

  3. General Investigational Approach • Determine if affected bag lots were received and which products were frozen in the recalled bags. • Follow the steps in the recall letter to return unused inventory. • Evaluate the potential impact on patients, operations & inventory.

  4. What additional investigation should be done if… • Products (351/361) in the recalled bags have been issued. • Product sterility results were negative. • No adverse reactions reported.

  5. Product Infused; No Reaction • Investigation & Follow-Up • Complete a deviation form. • Obtain more information from the company. • Check previous history to determine if this is the first recall. • Document event on product worksheet. • Follow Deviation Reporting SOP.

  6. What additional investigation should be done if… • Products (351/361) in the recalled bags have NOT been issued. • Product sterility results were negative.

  7. Product Not Infused • Investigation • Same as for infused products, but based on the information determine if the stored products are suitable for release. • Documentation • Same as for infused products. • Plus: • Notify recipient’s physician • Obtain patient’s consent • Follow Deviation Reporting SOP

  8. What additional investigation should be done if… • Products (351/361) in the recalled bags have been issued. • Product sterility results were negative. • Adverse reactions (shaking chills, fever) occurred.

  9. Products Infused; Reactions • Investigation & Follow-Up • Same as for infused products. • Plus: • Document recall on adverse reaction report. • Notify recipient’s physician. • Follow Adverse Reaction and Deviation Reporting SOP. • Notify Bags R Us.

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