DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0684-00-0576-01 |
Device Problems
Off-Label Use (1494); Calibration Problem (2890)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter name: (b)(6).Initial reporter occupation: administrator/ supervisor, icu manager.Additional initial reporter name: (b)(6).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 indicated that it was unable to calibrate the fiber optic sensor.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The off-label use was explained to the customer, and troubleshooting continued as if it was a femoral insertion.The console continued to attempt calibrations every 15 minutes and alarmed.The fluid lumen of the catheter was not available, as it had been capped.There was no other alternate arterial source.The console then successfully calibrated.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 aug-19 through jul-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
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