BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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Catalog Number H93811 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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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Event Description
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It was reported that condensation was observed inside the packaging of an unspecified number of sterile repeater pump tube sets.This was observed during setup and preparation.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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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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