Catalog Number IAB-05840-LWS |
Device Problems
Failure to Zero (1683); Connection Problem (2900)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: for related complaint refer to: mdr #1219856-2017-00221 and (b)(4).
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Event Description
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It was reported by the lead technician that they have a patient in the cath lab they just inserted a fiber optic sensor intra-aortic balloon (fos iab) and the two audible tones were not given when the fos was connected.Upon inspection, the tip is below the housing in the fos connector.As a result, the iab was removed and replaced with another iab.The patient was in poor condition upon arrival to the cath lab.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of "the tip is below the housing in the fos connector" is confirmed.Although, the root cause of the complaint is undetermined the fos was returned with a recessed connector; therefore, a light path could not be established between the sensor and the pump.The fiber was found intact and functional.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.A nonconformance has been initiated to further investigate the cause.Other remarks: for related complaint refer to: (b)(4).
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Event Description
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It was reported by the lead technician that they have a patient in the cath lab they just inserted a fiber optic sensor intra-aortic balloon (fos iab) and the two audible tones were not given when the fos was connected.Upon inspection, the tip is below the housing in the fos connector.As a result, the iab was removed and replaced with another iab.The patient was in poor condition upon arrival to the cath lab.
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Search Alerts/Recalls
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