An attorney reported that in around 2020, a patient began to experience complications with her feeding.As it turns out, her enteral feed pump set was allowing air to enter the tubing, which was causing vomiting, dehydration, hypoglycemia, abdominal pain, and abdominal distention in patients.On (b)(6), 2020 the patient was brought to the emergency department because she was lethargic, limp and feverish.She was found to have electrolyte abnormalities due to feeding intolerance.As a result of the electrolyte issues, she was also suffering from arrhythmia.In addition, she was documented as being dehydrated, hypoglycemic, vomiting, suffering from increased abdominal distention and had lost weight.She was hospitalized until (b)(6), 2020.Since then, the patient has continued to struggle with abdominal pain and distention, which have resulted in weight loss and intolerance to feeding.
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Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.
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