Model Number 0684-00-0576-01 |
Device Problems
Inability to Auto-Fill (1044); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
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Event Description
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It was reported that the customer had just inserted the intra-aortic balloon (iab) when the console indicated that there was an auto-fill failure.The customer attempted restarting and auto-filling again.There was no blood observed in the tubing and no visible kinks at that time.The helium tank was full and the valve was fully turned open.The customer was advised to use a new console or to remove that iab as it had been in standby for a while.It was later reported that the iab had been removed and a severe kink was discovered near the y-connector.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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Correction: section a patient information sex changed from female to male.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
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Event Description
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It was reported that the customer had just inserted the intra-aortic balloon (iab) when the console indicated that there was an auto-fill failure.The customer attempted restarting and auto-filling again.There was no blood observed in the tubing and no visible kinks at that time.The helium tank was full and the valve was fully turned open.The customer was advised to use a new console or to remove that iab as it had been in standby for a while.It was later reported that the iab had been removed and a severe kink was discovered near the y-connector.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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