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Model Number IPN000320 |
Device Problem
Output Problem (3005)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/13/2022 |
Event Type
Death
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Manufacturer Narrative
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Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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The report states, "inserting intra-aortic balloon pump into patient with cardiogenic shock.Balloon catheter inserted without incident.Substitute balloon was used that had no cal key so unable to zero fos key.Able to zero arterial pressure.No ecg tracing was showing on the screen.Connections were double-checked, electrodes were changed but still no ecg tracing to allow pump to use for auto-pilot mode.Also, there was no arterial pressure tracing despite adequate connections, which could have been used for iabp to sense and pump.This was noted after balloon catheter was already in-situ, so it was urgent to get it working.Unable to change mode to cpr mode either.Manual balloon inflations were initiated to prevent clotting.Had to send for replacement pump from ccu.By that time, patient had arrested, and cpr was initiated.Patient was in cardiogenic shock upon arrival.Despite coronary interventions, patient ended up in cardiac arrest and died".Multiple attempts were made to the customer to clarify information surrounding the death of the patient and performance of the pump.The customer did not respond to any of the inquiries.If further information is received on this complaint, the complaint file will be updated.
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Event Description
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The report states, "inserting intra-aortic balloon pump into patient with cardiogenic shock.Balloon catheter inserted without incident.Substitute balloon was used that had no cal key so unable to zero fos key.Able to zero arterial pressure.No ecg tracing was showing on the screen.Connections were double-checked, electrodes were changed but still no ecg tracing to allow pump to use for auto-pilot mode.Also, there was no arterial pressure tracing despite adequate connections, which could have been used for iabp to sense and pump.This was noted after balloon catheter was already in-situ, so it was urgent to get it working.Unable to change mode to cpr mode either.Manual balloon inflations were initiated to prevent clotting.Had to send for replacement pump from ccu.By that time, patient had arrested, and cpr was initiated.Patient was in cardiogenic shock upon arrival.Despite coronary interventions, patient ended up in cardiac arrest and died".Multiple attempts were made to the customer to clarify information surrounding the death of the patient and performance of the pump.The customer did not respond to any of the inquiries.If further information is received on this complaint, the complaint file will be updated.
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Manufacturer Narrative
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Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Additionally no recorder strip was returned for investigation.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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Search Alerts/Recalls
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