Model Number 3620-100 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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On completion of the investigation a follow up report will be submitted.
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Event Description
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Report received stated that the tube was kinked on the atrium drain, dry dual w/ac.
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Manufacturer Narrative
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On completion of the investigation a follow up report will be submitted.
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Event Description
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Report received stated that the tube was kinked on the atrium drain, dry dual w/ac.
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Event Description
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N/a.
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Manufacturer Narrative
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A review of the images provided show that there was a kink in the tubing on the patient line as described in the complaint details.The kink in the tubing although undesirable cosmetically still meets the flow requirements of the drain.Atrium medical corporation had introduced enhancements to the atrium chest drain family that simplify packaging and routine set-up of atrium chest drains.These enhancements factored-in clinician workflow exhibit multiple benefits, such as reducing costs associated with medical waste in the hospital as well as reducing manufacturing carbon footprint.As part of this initiative the wall thickness of the patient tube set was modified from.094+/-.012 inches for the 3/8 inch tubing and.094 +/- 0.16 inches on the 1/4 in tubing to a minimum specification of.088 +/-.006 inches.The dimensional changes were still within the original product requirements.Letters of these changes were sent out to the customers and distributers in february 2019.In an effort to ensure the product was still performing properly, a planned engineering study was conducted using 59 samples from inventory that were sterilized 3x times.This study was created to ensure the threshold for airflow going through the tube set did not drop below the required 7.5slpm after applying a 150gram weight to the tube set.The result was that the lowest value recorded was 24.85slpm.This is much higher than the threshold value.Although the kink in the tubing is undesirable the flow is very much still within the 7.5 slpm as stated in the product requirements.Based on the results of the investigation the kink in the tubing still meets the product requirement for flow as determined in the planned engineering study.A design control quality plan was initiated to reverse the change that called for the wall thickness reduction.The changes to revert back to the original wall thickness were completed in october 2021.The product in this complaint was manufactured in february 2021 before the changes were made.Based on the complaint details and investigation the complaint cannot be confirmed as the product has been shown to meet specification.A design control quality plan was initiated to reverse the change that called for the wall thickness reduction.The changes to revert back to the original wall thickness were completed in october 2021.H3 other text : device not available for return.
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Search Alerts/Recalls
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