BAXTER HEALTHCARE CORPORATION HD CARTRIDGE LINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number 103401 |
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 11/05/2022 |
Event Type
malfunction
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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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Event Description
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It was reported that during priming with a cartridge dialyzer line, an external saline leak from the ¿normal saline line¿ was observed.It was further reported the heparin connection port is broken.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The actual device was not received; however, eight (8) retained samples were evaluated.Visual inspection with the naked eye of the eight retention samples did not identify any abnormalities that could have contributed to the reported condition.Functional testing including leak testing was performed with no issues noted.The reported condition was not verified.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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