DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0684-00-0470-01 |
Device Problems
Filling Problem (1233); Off-Label Use (1494)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2021 |
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 console repeatedly indicated that there was an auto-fill failure and was unable to resume pumping.The customer had tried two consoles and experienced the same issue.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The customer was made aware of the off-label use.They then attempted pressing the fill key, but that was not successful.There were no visible kinks in the iab and no blood seen in the helium tubing.It was also confirmed that there was helium displayed in the tank.Due to the inability to restart pumping, the customer was then advised to consider removal/ replacement of the iab.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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Despite request and/ or customer indicated that the device would be returned; however, the device has not been returned to the manufacturer so we are unable to complete an evaluation.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 complaint trend data for the period jun-2019 through may-2021 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
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