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Model Number 500-55112 |
Device Problems
Device Alarm System (1012); Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/17/2021 |
Event Type
malfunction
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Event Description
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It was reported that a downstream drug occlusion occurred.Two ekosonic endovascular catheters were selected for use during a bilateral pulmonary embolism catheter directed thrombolysis procedure.A dual lumen sheath with a twist lock hemostasis valve was used with the ekos catheters.This type of sheath is advised against.Tiny clots were noted to be coming out of the wire lumen of the ekos catheter when it was introduced into the right lung.Approximately, 38 minutes into therapy, a downstream occlusion occurred to the right sided catheter.Troubleshooting included changing intravenous (iv) pump, multiple flushes of the iv line and pulling the catheter back 1 cm.None of these attempts were successful.At this time, the physician decided discontinue therapy on the right side and run normal saline through, while continuing therapy on the left side.Approximately,1 hour later, a drug infusion pump alert occurred to the left side catheter.Troubleshooting was unable to resolve this issue and the procedure was discontinued at this time.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: the ultrasonic core (usc) and infusion catheter (ic) were returned still together.The ic was hydrated, and the usc was removed.During the decontamination process, the drug line was unable to be flushed.There was blood noted in the drug and coolant luer.The device showed 05 of the 15 drug holes occluded with 10 holes clear.Two kinks were found on the ic: 46.5 cm and 97.2 cm from the strain relief.The device was run in a water bath for 15 minutes and the in-house alaris pump alarmed when hooked to the drug line running at 35 ml/hr.An air test was performed using a syringe, it was possible to flush the catheter with extreme resistance.Inspection of the remainder of the device revealed no damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information.
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Event Description
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It was reported that a downstream drug occlusion occurred.Two ekosonic endovascular catheters were selected for use during a bilateral pulmonary embolism catheter directed thrombolysis procedure.A dual lumen sheath with a twist lock hemostasis valve was used with the ekos catheters.This type of sheath is advised against.Tiny clots were noted to be coming out of the wire lumen of the ekos catheter when it was introduced into the right lung.Approximately, 38 minutes into therapy, a downstream occlusion occurred to the right sided catheter.Troubleshooting included changing intravenous (iv) pump, multiple flushes of the iv line and pulling the catheter back 1 cm.None of these attempts were successful.At this time, the physician decided discontinue therapy on the right side and run normal saline through, while continuing therapy on the left side.Approximately,1 hour later, a drug infusion pump alert occurred to the left side catheter.Troubleshooting was unable to resolve this issue and the procedure was discontinued at this time.No patient complications were reported.
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Search Alerts/Recalls
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