Catalog Number 47177E |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the bd alaris¿ smartsite¿ gravity set disconnected below the drip chamber after being connected.The following information was provided by the initial reporter: "bd smartsite gravity set disconnected, below drip chamber, from the iv fluids after it was connected.".
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Event Description
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It was reported that the bd alaris¿ smartsite¿ gravity set disconnected below the drip chamber after being connected.The following information was provided by the initial reporter: "bd smartsite gravity set disconnected, below drip chamber, from the iv fluids after it was connected.".
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Manufacturer Narrative
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Investigation summary: no photo or sample was received for the customer's complaint of connection issues.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.A device history record review could not be performed because a lot number was not provided by the customer.
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Search Alerts/Recalls
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