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Model Number 2420-0007 |
Device Problem
Stretched (1601)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/13/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.
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Event Description
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It was reported that during an infusion of alteplase at an unspecified rate, the night shift rn stated the iv tubing set "exploded" and was replaced with new tubing, however; the device continued to alarm for occlusion.The rn flushed the picc line by disconnecting tubing and received a positive blood return.After twenty minutes later; the device alarmed again for occlusion alarms; after flushing , the device alarmed again, the user opened the door to the device and observed a bulge in the silicone segment.The rn then changed out the devices to a new pump and new iv tubing, and the device infused without difficulty.There was no patient impact.
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Manufacturer Narrative
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No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
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Event Description
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It was reported that during an infusion of alteplase at an unspecified rate, the night shift rn stated the iv tubing set "exploded" and was replaced with new tubing, however; the device continued to alarm for occlusion.The rn flushed the picc line by disconnecting tubing and received a positive blood return.After twenty minutes later; the device alarmed again for occlusion alarms; after flushing , the device alarmed again, the user opened the door to the device and observed a bulge in the silicone segment.The rn then changed out the devices to a new pump and new iv tubing, and the device infused without difficulty.There was no patient impact.
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Search Alerts/Recalls
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