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Model Number ASPC28-3E. |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Currently waiting for the sample to be returned for evaluation.Once the investigation is complete a final report will be submitted.
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Event Description
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After having connected the patient air bubble alarm from the dialysis machine.Lots of bubbles on the arterial extension.Treatment interruption in order to check the luer lock connection: ok no issue.Treatment continuity but new air bubble alarm.Visually, air bubbles were drawn directly into the arterial extension.Treatment interruption: line disconnection, rinsing with water, insertion of tips.Visually, blood was flowing slightly between the lumen and the extension adaptor.Removal of the catheter then insertion of a new.The catheter seems to have a tear.The patient is now in good condition.
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Manufacturer Narrative
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The split cath was returned for evaluation in two (2) pieces.Approximately 5.3 cm of the lumen remains attached to the hub.The remainder of the lumen was also received.The device was both flushed and aspirated with no issues noted.No leaks, bubbles, or back flow were noted.No tear was noted.Issue cannot be replicated with the returned device.Complaint cannot be confirmed.The issue may have been with the bloodline used during the treatment and not with the catheter.The catheter was implanted and functioned for over 2.5 years with no reported problems.New bloodlines are used every treatment.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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