Model Number 0684-00-0576-01 |
Device Problems
Difficult to Flush (1251); Inappropriate Waveform (2536); Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2021 |
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 during intra-aortic balloon (iab) therapy the iab suddenly changed to a fiber optic waveform with a lot of artifact.It was noted that the patient had not been moved.The customer repositioned the iab higher in the aorta in response to an x-ray, but the waveform still did not appear correct.The fluid lumen was not being flushed as they had discovered that the lumen was clotted.The customer used a radial arterial line as the alternate arterial source.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.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period may-19 to apr-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4).
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Search Alerts/Recalls
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