Catalog Number UNKNOWN |
Device Problems
Off-Label Use (1494); Failure to Calibrate (2440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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).
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Event Description
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It was reported that shortly after inserting the intra-aortic balloon (iab), the console indicated that the optical sensor would not calibrate.The customer just wanted confirmation that the iab did not need to be removed due to this issue.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The customer stated they were aware that calibration is not expected due to the off-label use.The customer used the fluid lumen transduced as the arterial line.The customer was assured that supplying an alternate arterial source to the console was all that was required, and removal of the iab would be necessary if the iab itself was not functioning.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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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.The device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall 24 month product complaint trend data for the period may-19 to apr-21 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Complaint record id #(b)(4).H3 other text : device not returned.
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Event Description
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It was reported that shortly after inserting the intra-aortic balloon (iab), the console indicated that the optical sensor would not calibrate.The customer just wanted confirmation that the iab did not need to be removed due to this issue.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The customer stated they were aware that calibration is not expected due to the off-label use.The customer used the fluid lumen transduced as the arterial line.The customer was assured that supplying an alternate arterial source to the console was all that was required, and removal of the iab would be necessary if the iab itself was not functioning.There was no patient harm or adverse event reported.
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Search Alerts/Recalls
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