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Catalog Number UNKNOWN |
Device Problems
Leak/Splash (1354); Free or Unrestricted Flow (2945)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that 2 unspecified bd pri tubing sets experienced air bubbles/air in line and device damage/deformation.The following information was provided by the initial reporter: scenario 1 - nurse noticed collapsed iv bag and collapsed drip chamber and air line line all the way to the pump, but not below.No alarm.No patient harm.Scenario 2 - same nurse, same patient, new bag, new tubing.Same things above happened, however, in this scenario there was approximately 1/2 inch to 1 inch of air in the line below the device.No alarm.No patient harm.Nurse concerned and contacted biomed and risk mgmt.Risk mgmt has sequestered the one pcu, one lvp and both tubing sets that were used.No patient harm.Nurse concerned.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10 device available for eval: yes.D.10 returned to manufacturer on: 09/18/2020.Investigation conclusion: one sample was returned by the customer.It was reported that there was air in the line.The set was primed and infused at 100 ml / hr.The set was examined for defects in the tubing.No defects were observed.The customer complaint could not be verified because the failure could not be replicated.A device history record review could not be performed because a model or lot number was not provided by the customer.A root cause could not be determined because the failure could not be replicated.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text: see h10.
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Event Description
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It was reported that 2 unspecified bd pri tubing sets experienced air bubbles/air in line and device damage/deformation.The following information was provided by the initial reporter: scenario 1 - nurse noticed collapsed iv bag and collapsed drip chamber and air line line all the way to the pump, but not below.No alarm.No patient harm.Scenario 2 - same nurse, same patient, new bag, new tubing.Same things above happened, however, in this scenario there was approximately 1/2 inch to 1 inch of air in the line below the device.No alarm.No patient harm.Nurse concerned and contacted biomed and risk mgmt.Risk mgmt has sequestered the one pcu, one lvp and both tubing sets that were used.No patient harm.Nurse concerned.
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Search Alerts/Recalls
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