Model Number 2420-0007 |
Device Problems
Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Stretched (1601)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Race: caucasian.
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Event Description
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It was reported that iv lasix was infusing at 10ml/hr through primary set when a bubble formed in the pump segment of the iv set, just below the upper fitment.The bubble burst.There was no patient harm.
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Manufacturer Narrative
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The customer¿s report of a bubble formed in the pump segment of the iv set, just below the upper fitment was confirmed.The set was inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted discoloration and was weakened just below the upper fitment.It was also observed that the silicone segment and retainer ring had separated from the upper fitment and were reattached to the fitment but not fully reseated.Clear liquid was observed inside the set¿s tubing and drip chamber with no other abnormalities observed.The photo provided by the customer shows that a bubble/balloon occurred at the customer site.Functional testing resulted in no ballooning/bulging.The silicone segment was analyzed and the walls were found to be concentric.The root cause for the source of the excessive pressure is unknown.
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Event Description
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It was reported that iv lasix was infusing at 10ml/hr through the primary set when a "bubble" formed in the pump segment of the iv set, just below the upper fitment.Subsequently, the "bubble" did burst.It was confirmed that there was no patient harm as a result of this event.
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Search Alerts/Recalls
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