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
Leak/Splash (1354); Off-Label Use (1494)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2021 |
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 during intra-aortic balloon (iab) therapy the console generated a leak in iab circuit alarm.The alarm was sounding consistently for several hours and less frequently the prior evening shift.There was no blood in the helium tubing.The insertion was reported to be axillary, which is not the method described in the device instructions for use.Five hours prior, a chest film was obtained so another film was advised to confirm iab location.The customer was also advised to try the auto-fill key and drop the augmentation control.The customer attempted to roll the patient over slightly to remove the insertion dressing and inspected the insertion site.When they re-dressed the patient, the were able to resume pumping without alarms.Approximately one hour later, the customer reported that same alarm consistently.The customer went through the same troubleshooting steps again but was unable to continue pumping.There was still no blood seen in the helium tubing.Another chest film had not been obtained so the customer was advised again to get one and to consider contacting the physician for possible removal and replacement of the iab.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender tubing was also returned.A kink was observed on the catheter tubing and inner lumen approximately 76.2cm from iab tip.No blood was observed inside the iab catheter.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The reported event cannot be confirmed by the evaluation.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.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 jun-19 to may-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4).
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Event Description
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N/a.
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Search Alerts/Recalls
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