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Model Number 77100FD |
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 Date 01/31/2023 |
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 nurse (rn) noticed a large air bubble coming from the cannister, which measured 99cm (26 inches) and a second air bubble at the base of the tube towards the patient, which measured 12 cm (4 3/4 inches).The rn stopped the feeding pump, obtained new equipment and feeding bag, and started the set up with new equipment.This rn updated the leaving evening rn about defect found in air bag.She mentioned that she noticed an air bubble earlier and reprimed the line.The rn told her of previous experience and the steps to be taken if she encounter this situation again.There was no patient injury reported.
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Manufacturer Narrative
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A decontaminated sample was received at the plant for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual evaluation of the sample, the defect was confirmed; one line detached from the cassette.The root cause and action plan will be documented through a formal corrective/preventative action which has been initiated to address the reported condition to mitigate any further occurrences.
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Search Alerts/Recalls
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