Model Number 2426-0007 |
Device Problem
Stretched (1601)
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Patient Problem
No Information (3190)
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Event Date 05/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The customer¿s complaint of a balloon in pump segment was confirmed per photo received by the customer.Per the photo a bulge/balloon in the silicone segment tubing near the upper portion of the upper fitment was observed.The root cause for this event could not be determined.Additional patient information: african american.
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Event Description
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It was reported that the pump segment ballooned.It's unknown if an iv push was administered and if the tubing would have been clamped above the smart site during the iv push.The patient, who was being treated for pancreatis, was receiving lactated ringers at 200 ml/hour.There was no patient harm.
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Event Description
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Received a copy of the customer's medwatch which stated, "nurse was checking the patency of pt's iv line via flush iv tubing set up in a pump when she opened the door of the pump, she noted there was a balloon in the line tubing was removed and new tubing set up ballooned tubing was not saved for further investigation fda safety report id# (b)(4)" it's unknown if the tubing was clamped above the smartsite during the iv push.
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Manufacturer Narrative
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Additional information provided from mw5088049.
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Search Alerts/Recalls
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