INSTRUCTIONS FOR USE
FrontlineODP™ Unit (spray dried plasma) for transfusion
This Instructions for Use contains information on how to rehydrate a FrontlineODP Unit with a FrontlineODP SWFI (Sterile Water for Injection).
Indications:
FrontlineODP Unit is indicated in the management of traumatic hemorrhage where conventional plasma, such as FFP and PF24, is unavailable or impractical for use such as pre-hospital transfusions, rural/austere hospitals or military applications.
Contraindications:
• Where conventional plasma (such as FFP or PF24) is available
• To correct for coagulopathy in cases where a specific therapy would be more effective, such as vitamin K, cryoprecipitated AHF, prothrombin complex concentrates used to reverse warfarin, or specific coagulation factor concentrates
• When blood volume can be safely and adequately replaced with other volume expanders
Warnings and Precautions:
• FrontlineODP™ Unit must be completely rehydrated where upon visual inspection the plasma appears clear with no clumps or dry powder observed
• Do not use if upon visual inspection of the FrontlineODP™ Unit has evidence of container breakage or leakage after rehydration
Visual Description of the FrontlineODP Unit and SWFI
The FrontlineODP Unit (ODP) contains a light-yellow spray dried plasma powder. The transfusion bag has an IV hanger eyelet on one side and two (2) spike ports on the other side for rehydration and transfusion. When rehydrated with FrontlineODP SWFI, the FrontlineODP Unit should appear similar in appearance to liquid plasma. A single dose of rehydrated FrontlineODP Unit is approximately 200 mL.
Rehydrating a FrontlineODP Unit:
1. Remove the FrontlineODP SWFI (SWFI) and FrontlineODP Unit from the overwrap pouch prior to use.
2. Close the clamp on the transfer set and uncap one end of the spike.
3. Open the twist off cap of the SWFI container and insert spike on the transfer set into the SWFI container.
4. Open the twist off cap of the FrontlineODP™ unit and insert the other spike on the transfer set into the FrontlineODP™ Unit.
5. Release the clamp on the transfer set and drain the entire contents of the SWFI into the FrontlineODP™ Unit.
6. When the SWFI is completely transferred into the FrontlineODP™ Unit, close the clamp on the transfer set.’
7. Give the FrontlineODP™ Unit a few strong shakes for approximately 5 seconds until the dried plasma powder is dispersed in the bag.
8. Mix using an undulating figure 8 motion until all the powder is visibly wet.
9. Start pinching visible clumps while mixing until all the powder goes into solution.
10. The rehydration is complete when there are no clumps or powder left in the FrontlineODP™ Unit. Foaming will dissipate within minutes.
Left: Dried plasma powder is not yet visibly wet and remains a pale light color when dry, Middle: Majority of the powder is saturated and darker in color, Right: FrontlineODP™ Unit should appear similar in appearance to liquid plasma
Storage Instructions
FrontlineODP™ Unit storage:
• 1-24°C for 6 months
• For long term storage, store at 1-6°C up to 24 months
Rehydrated FrontlineODP™ Units can be stored per AABB Circular of Information
• 4 hours at room temperature (20-24°C)
• 24 hours at refrigeration (1-6°C)
Disposal
Instructions
Follow standard practices for disposal of biohazardous waste.