Model Number 2420-0007 |
Device Problems
Stretched (1601); Material Deformation (2976)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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The customer¿s report that the iv tubing issues was confirmed.The reported tubing issue was identified to be a balloon in the silicone pumping segment.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Further visual inspection of the inner diameter of the silicone tubing observed the tubing to be concentric.Functional testing of previous complaints with the failure mode of ¿balloon/bulge in silicone tubing segment¿ was performed by placing the infusion set in an alaris pump module.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.
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Event Description
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It was reported that the tubing was defective.Although requested, there has been no impact to patient response or additional event information made available to date.
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Event Description
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It was reported that the tubing was defective.Although requested, there has been no impact to patient response or additional event information made available to date.
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Manufacturer Narrative
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Correction: device evaluated by mfg h3: revised to yes.
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Search Alerts/Recalls
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