Catalog Number 0998-00-0800-53 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Code Available (3191)
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Event Date 11/02/2017 |
Event Type
Injury
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.Additional information has been requested, and we will report accordingly if it becomes available.
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Event Description
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Facility perfusionist reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) falsely alarmed ¿iab disconnected".The perfusionist replaced the iabp and assured that all helium connections were secure and that the correct helium extension tubing was used.The second iabp experienced the same alarm and is being reported separately.No death or injury was reported but the customer did report there was a delay in therapy as they had to switch machines which caused some patient instability.
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Manufacturer Narrative
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The customer biomed reported that he checked the error logs of the cardiosave intra-aortic balloon pump (iabp) and found the alarm documented in the logs.But the biomed could not find any issues causing the error.The biomed connected the iabp to the simulator for testing, disconnected the balloon and the iabp alarmed appropriately.He then checked all the connections and ran the iabp on simulator for several hours with no problems.The iabp was then returned to service.
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Event Description
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Facility perfusionist reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) falsely alarmed ¿iab disconnected".The perfusionist replaced the iabp and assured that all helium connections were secure and that the correct helium extension tubing was used.The second iabp experienced the same alarm and is being reported separately.No death or injury was reported but the customer did report there was a delay in therapy as they had to switch machines which caused some patient instability.
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Manufacturer Narrative
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Corrected: (serial number from (b)(4) to (b)(4)).The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.
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Event Description
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Facility perfusionist reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) falsely alarmed ¿iab disconnected".The perfusionist replaced the iabp and assured that all helium connections were secure and that the correct helium extension tubing was used.The second iabp experienced the same alarm and is being reported separately.No death or injury was reported but the customer did report there was a delay in therapy as they had to switch machines which caused some patient instability.
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Search Alerts/Recalls
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