Catalog Number IAB-05840-LWS |
Device Problems
Failure to Zero (1683); Connection Problem (2900)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/05/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that the event involved a fiberoptic intra-aortic balloon (iab) that failed to register the fiber optic sensor (fos).There was no patient interaction.Additional information received: the rn stated that the event took place in the cath lab and occurred prior to the insertion of the iab.The fos failed to register and as a result, another iab was used.There was a delay of ten minutes but no patient complications and no medical/surgical intervention required.
|
|
Manufacturer Narrative
|
(b)(4).Teleflex received the device for investigation.The reported complaint of fos would not zero is confirmed.Although, the root cause of the fos fiber being broken could not be determined the light path could not be established between the sensor and the pump.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 revised risk.This issue will be monitored for any developing trends.
|
|
Event Description
|
It was reported that the event involved a fiberoptic intra-aortic balloon (iab) that failed to register the fiber optic sensor (fos).There was no patient interaction.The rn stated that the event took place in the cath lab and occurred prior to the insertion of the iab.The fos failed to register and as a result, another iab was used.There was a delay of ten minutes but no patient complications and no medical/surgical intervention required.
|
|
Search Alerts/Recalls
|