Model Number J011RO |
Device Problem
Air/Gas in Device (4062)
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Patient Problems
Discomfort (2330); Abdominal Distention (2601)
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Event Date 07/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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Event Description
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The customer reported that air had been leaking from the fitting part of the aff valve and the cock when the tube was connected to the feeding set and pump.It was said that there was about 10cm of air bubbles occurring about five times while feeding 200cc.This caused discomfort to the patient due to stomach bloating so it had to be constantly monitored which was a hassle for the patient.The formula being used was enevo (50cc of which was diluted with 190cc of hot water) and solita-t granules no.3 (450g which was dissolved with 250cc of hot water).The duration of use was said to be about 10 minutes per formula.There was no other patient harm.
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Manufacturer Narrative
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Section b5 has been updated to include additional information provided on july 20, 2021.
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Event Description
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The customer reported that air had been leaking from the fitting part of the aff valve and the cock, when the tube was connected to the feeding set and pump.It was said that there was about 10cm of air bubbles occurring about five times while feeding 200cc.This caused discomfort to the patient due to stomach bloating so it had to be constantly monitored which was a hassle for the patient.The formula being used was enevo (50cc of which was diluted with 190cc of hot water) and solita-t granules no.3 (450g which was dissolved with 250cc of hot water).The duration of use was said to be about 10 minutes per formula.There was no other patient harm.Additional information provided on july 20, 2021 stated that a lot of air got mixed in the lower part of the pump set after a while but no air inclusion was observed in the upper part of the pump set.The customer had never experienced this before.
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Search Alerts/Recalls
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