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Catalog Number H938724 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2022 |
Event Type
malfunction
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Event Description
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It was reported that non-lipid bags were cloudy during programming/setup with an unspecified quantity of em2400 valve sets.Lipids were on ports 2, 4, and 5, and when the valve set was changed to a different lot, the customer was able to set up and run bags with no issues.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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G1: manufacturing facility-this device was manufactured at one of the two following manufacturing sites: availmed c.Industrial lt.001 mz.105 no 20905 int a, col cd ind.Tijuana, baja california 22444, mexico or baxter healthcare ¿ englewood 14445 grasslands dr englewood, co.80112 united states.H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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