Model Number 2420-0007 |
Device Problems
Material Rupture (1546); Stretched (1601); Material Deformation (2976)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 10/30/2019 |
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.Patient's demographics requested, but was not provided.
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Event Description
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It was reported that the line occluded and when the rn opened the pump module door the iv tubing set was found to have a balloon in the silicone segment that " burst".
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Event Description
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It was reported that the line occluded and when the rn opened the pump module door the iv tubing set was found to have a balloon in the silicone segment that " burst".There was no patient impact.
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Event Description
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It was reported that the line occluded and when the rn opened the pump module door the iv tubing set was found to have a "balloon" in the silicone segment that " burst".It was confirmed that there was no patient impact related to this event.
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Manufacturer Narrative
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The customer¿s report that the line occluded was not confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted separation between the silicone pump segment and the upper fitment.The ring retainer was not received with the set however a ring retainer indentation was observed at the end of the silicone segment indicating the set had been assembled with the ring retainer.The silicone tubing pump segment distal to the upper fitment was slightly stretched and misshapen, had a different appearance than the rest of the silicone tubing, and readily kinked and twisted.Examination under magnification found the silicone segment to be concentric.The customer¿s report that the line ¿burst¿ was confirmed to be a separation.The root cause of the separated tubing is due to a balloon segment forming and then ¿bursting¿ due to the excess pressure.The root cause for the source of the excessive pressure is unknown.
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Search Alerts/Recalls
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