Model Number N/A |
Device Problem
Inability to Auto-Fill (1044)
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Patient Problem
Chest Tightness/Pressure (2463)
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Event Date 12/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.(b)(4) was not requested in connection with this event.A supplemental report will be submitted if additional information is made available.
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Event Description
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It was reported that a patient was experiencing continued chest pressure and the cardiosave intra-aortic balloon pump (iabp) was initiated for coronary perfusion and transfer for bypass.However, ¿autofill failure¿ occurred on the iabp during use with a 50cc sensation balloon.The customer stated that all the on-screen instructions were followed, but this did not resolve the issue; customer then switched to a 40cc balloon catheter and the iabp functioned properly.
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Event Description
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It was reported that a patient was experiencing continued chest pressure and the cardiosave intra-aortic balloon pump (iabp) was initiated for coronary perfusion and transfer for bypass.However, ¿autofill failure¿ occurred on the iabp during use with a 50cc sensation balloon.The customer stated that all the on-screen instructions were followed, but this did not resolve the issue; customer then switched to a 40cc balloon catheter and the iabp functioned properly.No patient harm or serious injury was reported.
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Search Alerts/Recalls
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