Model Number N/A |
Device Problems
No Audible Alarm (1019); Device Contamination with Body Fluid (2317)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge representative has advised that the safety disk assembly, condensation removal module (crm), and the tubing assembly have been replaced.Testing is ongoing and the iabp unit has not been returned to use.A supplemental report will be submitted when additional information is provided.
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Event Description
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It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) experienced a blood back event.It was noted that the iabp unit did not generate an alarm when blood was observed in the helium extension tube.Patient therapy was stopped, the intra-aortic balloon (iab) was replaced, and therapy was resumed without issue.There was no patient harm or injury and no adverse event was reported.
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Event Description
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It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) experienced a blood back event.It was noted that the iabp unit did not generate an alarm when blood was observed in the helium extension tube.Patient therapy was stopped, the intra-aortic balloon (iab) was replaced, and therapy was resumed without issue.There was no patient harm or injury and no adverse event was reported.
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Manufacturer Narrative
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A getinge representative has advised that after replacing of the parts, all calibration, functional and safety checks to meet factory specifications were performed.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
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Event Description
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It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) experienced a blood back event.It was noted that the iabp unit did not generate an alarm when blood was observed in the helium extension tube.Patient therapy was stopped, the intra-aortic balloon (iab) was replaced, and therapy was resumed without issue.There was no patient harm or injury and no adverse event was reported.
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Search Alerts/Recalls
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