BAXTER HEALTHCARE CORPORATION HD CARTRIDGE LINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number 101025 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(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 during the priming of a cartridge line, an external fluid leak from a crack located at the initial stop of the heparin line and cartridge was observed.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Additional information: h3, h4, h6 and h10.The actual device was not available; however, (4) photographs of the sample were provided for evaluation.Visual inspection of the provided pictures identified a breakage in heparin tubing (maceration) which caused the leak.The reported condition was verified.The cause of the condition (maceration) was determined to be a manufacturing issue.A nonconformance has been opened to address this issue.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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