BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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Catalog Number H93811 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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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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Initial reporter postal code: (b)(6).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 a sterile repeater pump tube set had plastic in the line.This issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H4: the lot was manufactured from april 02, 2019 - april 03, 2019.H10: the device was received for evaluation.Visual inspection was performed which observed particulate matter using stereomicroscopy and fourier transform infrared spectroscopy (ftir) test; a single, white particle with a knotted ribbon morphology was identified.The particulate matter was found to be silicone.A silicone section is a feature of the tubing.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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