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Model Number N/A |
Device Problems
Difficult to Insert (1316); Failure to Advance (2524); Device Displays Incorrect Message (2591)
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Patient Problems
Death (1802); Pulmonary Edema (2020)
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Event Date 08/30/2017 |
Event Type
Death
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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 reviewed per company standard operating procedure since the serial number was not provided.The reporter name was abbreviated due to the name exceeding maximum characters.The complete name is "sangsuk (suki) sifrit garza".This report has been sent per company protocol of co-reporting when the event description entails a serious injury or death regarding the iabp/ iab.The customer confirmed that there was no malfunction with the iabp, then performed functional and safety checks to meet factory specifications, and iabp was then released back to clinical use.There was no further information provided.
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Event Description
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On (b)(6) 2017, while in use on a patient, the intra-aortic balloon pump (iabp) alarmed due to the intra-aortic balloon (iab) having difficulties upon insertion.It was reported that after intra-aortic balloon (iab) insertion into the right femoral artery was unable to advance.The first iab was removed.The 2nd iab was successfully inserted and left in to treat shock less than 48 hours.The patient experienced on (b)(6) 2017 due to pulmonary edema, edp of 38 mm hg, post pea, post stemi.The customer reported that the patient death was not attributed to the iabp/ iab.Mfg report number 2248146-2017-00619 and 2248146-2017-00412 were opened to address the iab's used.
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Event Description
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On (b)(6) 2017, while in use on a patient, the cs300 intra-aortic balloon pump (iabp) alarmed due to the intra-aortic balloon (iab) having difficulties upon insertion.It was reported that after intra-aortic balloon (iab) insertion into the right femoral artery was unable to advance.The first iab was removed.The 2nd iab was successfully inserted and left in to treat shock less than 48 hours.The patient experienced on (b)(6) 2017 due to pulmonary edema, edp of 38 mm hg, post pea, post stemi.The customer reported that the patient death was not attributed to the iabp/ iab.Mfg report number 2248146-2017-00619 and 2248146-2017-00412 were opened to address the iab's used.
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Search Alerts/Recalls
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