Catalog Number 0684-00-0475 |
Device Problems
Device Alarm System (1012); Leak/Splash (1354); Device Contamination with Body Fluid (2317)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The device has not been returned to the manufacturer, so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy there was a leak, but the iab pump (iabp) did not stop working and there was no blood back detection error.Blood went into the safety disk and related pneumatic circuit.When the iabp was opened blood was noted on power management circuit board.Now safety disc, related pneumatic and power management board are not useable and need to be changed.There was no reported injury to the patient.
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Manufacturer Narrative
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Complaint # (b)(4); record id 191726.
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy there was a leak, but the iab pump (iabp) did not stop working and there was no blood back detection error.Blood went into the safety disk and related pneumatic circuit.When the iabp was opened blood was noted on power management circuit board.Now safety disc, related pneumatic and power management board are not useable and need to be changed.There was no reported injury to the patient.
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy there was a leak, but the iab pump (iabp) did not stop working and there was no blood back detection error.Blood went into the safety disk and related pneumatic circuit.When the iabp was opened blood was noted on power management circuit board.Now safety disc, related pneumatic and power management board are not useable and need to be changed.There was no reported injury to the patient.
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Manufacturer Narrative
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Evaluation method codes [from]: blank [to]: analysis of production records; 3331.Reference complaint # (b)(4); record id (b)(4).
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Search Alerts/Recalls
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