BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, TRIFURC, ST; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number H93863 |
Device Problems
Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).(b)(4).The device was received for evaluation.Visual inspection was performed which observed leakage and tear in the section of the tubing that wraps around the rotor.A functional testing was performed which revealed a leak on the affected area.The reported condition was verified.The cause of the condition was not 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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Event Description
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One trifurcated fluid transfer tube set was returned with a leakage and tear in the section of the tubing that wraps around the rotor.This was identified during preparation.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Corrective information: unknown lot number does not exist based on additional information.Additional information/ correction was added to h10: h10: the product trifurcated fluid transfer tube set with unknown lot number does not exist.Therefore, all information was captured in the mdr 1416980-2020-03173.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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