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Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Spontaneous call from pt who reported that her tubing has been leaking occasionally and one day she had to change it 3 times.She stated that it doesn't always leak.She has not informed a nurse or doctor's office about this issue.She noticed this issue while using the product but denied any clinical injuries.She does not have the possibly defective tubing.No other information provided.Reported to (b)(6) by pt/caregiver.
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Search Alerts/Recalls
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