BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, UNIV ENDS,; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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Catalog Number H93821 |
Device Problems
Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that a fluid transfer tube set leaked and ¿has been torn¿.The event was further described as during use for filtering castor oil through a 0.2 micron filter, the transfer set has broken at the level of the rotor".The device was being used with a baxa repeater pump.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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Additional information: h4, h6, h10.H4: the lot was manufactured from march 31, 2021 to april 05, 2021.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was discarded; 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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