The unit was received and inspected.The blood bag was found to be still in the un-deployed position with approximately 150mls of blood within bag.The line clamp was in the released position.There were no visible signs of damage, tears or holes in the blood bag.To determine the functionality of the returned blood bag the device had to be completely disinfected.The bag was deployed as instructed in the instructions for use (ifu) and the blood bag opened without issue even with all the dried blood within the bag.Upon completion of the disinfecting the blood bag was compressed to lock it in the closed un-deployed state as it is shipped.The bottom of the blood bag was then triggered to open as stated in the (ifu).The blood bag opened without issue to its full capacity.This functionality test was conducted several times without any issues deploying the blood bag, therefore the reported complaint was unable to be determined.A review of the device history records indicates that this lot of blood bags met all specifications.Clinical opinion: the chest drain auto-transfusion system is used to collect autologous blood from the patient¿s pleural cavity or mediastinum for reinfusion purposes in postoperative and trauma blood loss management.The instructions for use (ifu) states users should be familiar with thoracic surgical procedures and techniques before using a chest drain and to please refer to all manufacturers¿ instructions for use, indications, contraindications, warnings and cautions for anticoagulant medications, microemboli filters, i.V.Blood administration sets, blood compatible infusion pumps and pressure infuser devices prior to use with this ats bag.
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