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PLASMACELLC Product Performance Report Important: If reaction or injury has occurred call Fresenius Kabi PostMarket Quality Assurance at 18009336925. Incident Date: Instrument S/N.: Software Version:.

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How to fill out the PLASMACELL-C Product Performance Report online

This guide provides detailed instructions on completing the PLASMACELL-C Product Performance Report online. It aims to simplify the process and ensure you provide accurate and necessary information.

Follow the steps to complete the report effectively.

  1. Press the ‘Get Form’ button to access the form and open it in your editor.
  2. In the first section, fill in the incident date and the instrument serial number. Ensure these details are accurate to help with the processing of the report.
  3. Next, provide the software version, product code, lot number, and UDI number. These identifiers are crucial for tracking the specific product involved in the incident.
  4. Fill out the batch tag information, including the batch tag time and batch tag number. This information helps link the report to the specific batch of products.
  5. Indicate the donor bleed number and the volume of plasma collected. Be precise with the volume to ensure accurate assessments.
  6. Select when the problem was detected by marking the appropriate option from 'Before Use' to 'Reinfusion.' Check all that apply.
  7. Identify the problem type by marking all applicable options, such as 'Kinked' or 'Blood/Plasma Leak.' The greater the detail, the better the analysis can be.
  8. Answer the subsequent questions regarding adverse events, the completion of the procedure, and any product loss. Be truthful to maintain the integrity of the report.
  9. If you do not wish to receive response letters, check the provided box. Also, enter the email address for the letter recipient if applicable.
  10. Review the diagram of the PLASMACELL-C Separation Disposable Set and circle the specific components where the incident occurred.
  11. In the 'Additional Problem Description' section, provide any extra information or explanations about the incident.
  12. Complete the customer information section by providing the account number, facility name, contact person, and operator name.
  13. Finally, ensure you have a center authorized signature and date before saving your changes. Submit the form as outlined, including faxing or emailing it with a copy of this report when returning a kit.

Complete your PLASMACELL-C Product Performance Report online now to ensure proper documentation and support.

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