1 / 9

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.

kristine
Download Presentation

Problem Management Scenario # 1

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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.

More Related