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Model Number 775659 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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The customer reported that the tubing is defective and it makes bubbles during a feed.It also appears that the tubing is pinched and causes feed errors.Per additional information received on 25-jul-2022, nothing was replaced.They we¿re just having problems with the wiring tube as it gets bubbles inside and blocks the machine.When they change it, sometimes it works, and sometimes they need to change it five times.There¿s a defect with the wiring tube itself.They have had the machine and formula checked and they are fine.
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Manufacturer Narrative
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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.Photos were provided for review.Examining the pictures can detect a kink on the tube, and air bubbles along the tube.Two used samples were also received for evaluation.A visual and functional inspection was performed on the returned samples and no issues were found; the problem shown in the photos was not able to be duplicated on the physical samples.Based on the available information, a root cause could not be determined.A corrective and preventive action is not required at this time.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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