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Lot Number 3983334 |
Device Problems
Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
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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 patient reporting cassette had major holes and leaked mixed drug and diluent lot 3983334, expiration 06/19/2025.No adverse effects reported.Patient has other cassettes to use.Did the reported product fault occur while in use with the patient? - no; did the product issue cause or contribute to patient or clinical injury?- no; is the actual device available for investigation? -yes; did we [mfr] replace device?-yes; did the patient have a backup device they were able to switch to? -yes; if yes, was the patient able to successfully continue their infusion? -yes; is the infusion life-sustaining? -yes; what is the outcome of the event? resolved.Reported to (b)(6) by pt/caregiver.
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Search Alerts/Recalls
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