BAXTER HEALTHCARE CORPORATION HD CARTRIDGE LINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number 101025 |
Device Problems
Break (1069); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter name and address: (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 use with a hd cartridge line, the heparin line was noted to be broken and an external leakage of saline solution was observed.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A total of two pictures of the actual sample were visually inspected.Maceration was observed between the heparin line and the cartridge, which caused the heparin line to rupture from the cartridge.The reported condition was verified.The cause is a manufacturing related 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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