Model Number N/A |
Device Problem
Connection Problem (2900)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this iabp unit is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.The customer has not requested getinge to evaluate the iabp in connection with this event.However, the customer has advised that they have no any additional information to add.
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Event Description
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It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) was not indicating that the fiber optic (fo) catheter was connected.There was no arterial signal or waveform on the iabp.There was no other pump available to switch to so was not able to troubleshoot whether it was the pump or catheter.A getinge representative instructed the customer to disconnect the fo plug and the fluid lumen still did not appear on the screen.The getinge representative, was unable to have the customer switch to another console to check the pump connection because their pumps were all in use with a rental already ordered.The surgeon arrived just when the getinge representative was having the nurse switch to the radial arterial transducer.He ¿flushed it¿ and the arterial line signal appeared and was intact.Afterwards the getinge representative, explained to the nurse about flushing only on standby.There was no patient harm and no adverse event was reported.
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Event Description
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It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) was not indicating that the fiber optic (fo) catheter was connected.There was no arterial signal or waveform on the iabp.There was no other pump available to switch to so was not able to troubleshoot whether it was the pump or catheter.A getinge representative instructed the customer to disconnect the fo plug and the fluid lumen still did not appear on the screen.The getinge representative, was unable to have the customer switch to another console to check the pump connection because their pumps were all in use with a rental already ordered.The surgeon arrived just when the getinge representative was having the nurse switch to the radial arterial transducer.He ¿flushed it¿ and the arterial line signal appeared and was intact.Afterwards the getinge representative, explained to the nurse about flushing only on standby.There was no patient harm and no adverse event was reported.
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Manufacturer Narrative
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The customer has advised that the iabp has been cleared for clinical use.
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Search Alerts/Recalls
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