Model Number 777501 |
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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Event Description
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The customer reported that air entered the tubing during administration of the nutrient when the purge has been completed.There was no harm reported.
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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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Manufacturer Narrative
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Section /d2a/d2b (product code/ common device name): originally reported as knt - tubes, gastrointestinal (and accessories) and should be lzh - pump, infusion, enteral.
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Manufacturer Narrative
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Section b5 has been updated to include additional information.The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Per customer, the sample was discarded.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.
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Event Description
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The customer reported that air entered the tubing during administration of the nutrient when the purge has been completed.There was no harm reported.Additional information was received and stated that the air bubbles appeared after 2 to 3 hours after starting the pump.
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Search Alerts/Recalls
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