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Model Number 7300 |
Device Problems
Leak/Splash (1354); Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/18/2020 |
Event Type
malfunction
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Event Description
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Information was received that a smiths medical admin set when checking the medical fluid-filled cassette prior to the use of it, the customer noticed the part where the cassette and the tubing were connected was partially torn, and medical fluid was leaking from there.No adverse patient effects were reported.
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Manufacturer Narrative
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One picture of the cadd administration set was received for evaluation.In the picture, it could be observed that the tube was damaged.One cadd administration set with part number 21-7302-24 lot number 3941140 with received in used condition inside a plastic bag with its original open packaging.The sample was visually inspected at a distance of 12 to 16 under normal conditions of illumination; no damages or other workmanship defects were detected.A syringe was used to infuse water into the cassette bag; a leak was detected on the bag.Leak testing was reviewed to ensure that measures are within specification, no discrepancies were found.The reported issue was able to be confirmed.The most likely cause of the issue was that the tube was damaged after it left the manufacturing facility.
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Search Alerts/Recalls
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