Catalog Number 106697 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that during continuous veno-venous hemodiafiltration, air was noted in the pre-blood pump (pbp) line of three prismaflex sets and upon closer inspection, it was identified that the air bubbles appeared to be originating in the pbp pump segment where the pbp line exits the cartridge from the pbp pump.The customer tapped the line and the bubbles progressed through the line, however, air bubbles were continuously being produced from where the pbp line connects to the cartridge and exits the pump.There were no bubbles in the pbp bag or in the line from the pbp bag to the pump.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Additional information: adverse event problem and additional narrative.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: a review of complaints reporting air ingress into the prismaflex sets was made as part of a health hazard assessment related to a similar hazardous situation.The review concluded that the risk of infection due to air ingress is unlikely and no cases of infection has been reported for this or similar types of hazardous situations.Therefore, the reported event does not have the likelihood to cause or contribute to death or serious injury.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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