Catalog Number IAB-05840-LWS |
Device Problems
Material Separation (1562); Connection Problem (2900); Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the intra-aortic balloon (iab) blue fiber optic connector would not "click" into place on pump.After multiple attempts, the blue connector came separated from yellow cable.As a result, a second iab was inserted.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).No iab parts was returned to teleflex chelmsford for investigation.The reported complaint of iab fos connection problem is confirmed based on customer pictures provided with the complaint.The product was not returned for investigation.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
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Event Description
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It was reported that the intra-aortic balloon (iab) blue fiber optic connector would not "click" into place on pump.After multiple attempts the blue connector came separated from yellow cable.As a result, a second iab was inserted.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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