SPECTRUM MEDICAL/QURA SRL QUANTUM PERFUSION DUAL LUMEN CANNULA 31F; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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Model Number DL31F-V0 |
Device Problems
Loss of or Failure to Bond (1068); Disconnection (1171); Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/19/2022 |
Event Type
malfunction
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Event Description
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When the perfusionist was connecting the quantum arterial limb to the new ecmo circuit, the factory bonded connection on the venous limb was loose and came disconnected.Few months back, our hospital was notified from the manufacturer about events at an outside hospital and recommended the avoidance of alcohol use.No official fda recall issued.Described as alcohol degraded the adhesive in the bounding cannula.
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Event Description
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When the perfusionist was connecting the quantum arterial limb to the new extracorporeal membrane oxygenation (ecmo) circuit, the factory bonded connection on the venous limb was loose and came disconnected.Few months back, our hospital was notified from the manufacturer about events at an outside hospital and recommended the avoidance of alcohol use with reference to the instructions for use (ifu) of the device.Per staff, reeducation was immediately shared, and signage was posted as additional reminders to avoid all alcohol with the device.
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Search Alerts/Recalls
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