Model Number 0684-00-0480-07 |
Device Problems
Material Deformation (2976); Pressure Problem (3012)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 10/28/2022 |
Event Type
Death
|
Manufacturer Narrative
|
Event site postal code - (b)(6).Complete initial reporter name - (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.Complaint record id # (b)(4).
|
|
Event Description
|
It was reported that during intra-aortic balloon (iab) therapy, the augmentation pressure displayed on the cardiosave intra-aortic balloon pump (iabp) was abnormal.The customer observed inaccurate pressure reading which resulted to less augmentation.It was explained that the issue was suspected to be due to a bad pressure transducer, blockage in inner lumen, and a kink in iab.The customer reported that the patient expired.This report is for the iab.A separate report for the cardiosave iabp has been submitted under mfg report number - 2249723-2022-02862.
|
|
Manufacturer Narrative
|
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).
|
|
Event Description
|
N/a.
|
|
Search Alerts/Recalls
|