Model Number 2426-0007 |
Device Problem
Stretched (1601)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Patient's demographics requested, but was not provided.
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Event Description
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It was reported that during an infusion of normal saline (600ml / 75c/hr.), the pump module while connected to the patient alarmed air-in-line.When the nurse opened the door, she noticed the line had a large bulge below the upper fitment.There was no patient impact.
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Event Description
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It was reported that during an infusion of normal saline (600ml / 75c/hr.), the pump module while connected to the patient alarmed air-in-line.When the nurse opened the door, she noticed the line had a large bulge below the upper fitment.There was no patient impact.
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Manufacturer Narrative
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The customer¿s report that the line had a balloon below the upper fitment was confirmed by visual inspection of the as-received sample.The balloon was located on the silicone tubing below the upper fitment of the pump segment.Further visual inspection under magnification found the walls of the silicone tubing segment to be concentric.Previously investigated complaints for this same failure mode determined that the ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.The customer¿s report that the pump module alarmed for air-in-line was not confirmed.The root cause of the customer¿s experience was not identified because no air-in-line alarms or visual air-in-line boluses were replicated during functional testing.The device pump and pcu that were in use at the time of the customer event were not returned for investigation a device history record for model: 2426-0007 with lot number: 20026609 was performed.The search showed that a total of (b)(4) units were built in 1 lot on 20feb2020.The search showed that there were no quality notifications for the failure mode reported by the customer.
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Search Alerts/Recalls
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