INTERA ONCOLOGY HEPATIC ARTERY INFUSION PUMP SINGLE CHAMBER; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number AP03000H |
Device Problems
Defective Component (2292); Inaccurate Delivery (2339)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2022 |
Event Type
malfunction
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Event Description
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(b)(4) single chamber pump reservoir was not emptying properly.Patient arrived on (b)(6) 2022 for his first dose of hepatic arterial infusion (hai) floxuridine (fudr) via the intera pump.It took multiple attempts to access the patient's intera pump.A test was performed that led the medical team to identify the issue was located within the chamber of the pump.Fda safety report id# (b)(4).
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Search Alerts/Recalls
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