DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Catalog Number 0684-00-0605 |
Device Problems
Restricted Flow rate (1248); Pressure Problem (3012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Event site zip code: (b)(4).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 on the third day of intra-aortic balloon (iab) therapy, the console generated an iab catheter required inspection alarm.After the alarm sounded, it was noticed that the arterial pressure waveform was flat.Because the patient was finishing up iab therapy when the event occurred, the iab was removed safely.There was no reported injury to the patient.
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Event Description
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It was reported that on the third day of intra-aortic balloon (iab) therapy, the console generated an iab catheter required inspection alarm.After the alarm sounded, it was noticed that the arterial pressure waveform was flat.Because the patient was finishing up iab therapy when the event occurred, the iab was removed safely.There was no reported injury to the patient.
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Manufacturer Narrative
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Approximately 74.17 cm, 74.93 cm and 76.2 cm from the iab tip.The optical fiber was found to be broken within the membrane at 23.62 cm.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen and was unable to insert the guide wire.The inner lumen was discovered to be occluded with blood and could not be cleared.An underwater leak test of the balloon, catheter, y-fitting, inner lumen, extracorporeal tubing, pressure tubing, and extender tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped but was unable to pump to 90% volume.The condition of the iab as received indicated three kinks on catheter tubing.Even though we did not replicate the reported alarm, a kink can cause the issue.We are unable to conclusively determine when these kinks may have occurred.The optical fiber was found to be broken confirming the difficulty to pressure monitor.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).
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Event Description
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It was reported that on the third day of intra-aortic balloon (iab) therapy, the console generated an iab catheter required inspection alarm.After the alarm sounded, it was noticed that the arterial pressure waveform was flat.Because the patient was finishing up iab therapy when the event occurred, the iab was removed safely.There was no reported injury to the patient.
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Manufacturer Narrative
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Return to manufacture date, date received by mfg, device not eval provide code,evaluation method codes ,evaluation result codes, evaluation conclusion codes, addtl mfg narrative/corr.Data.The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint #: (b)(4).
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