Catalog Number 0684-00-0604 |
Device Problems
Optical Problem (3001); Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2024 |
Event Type
malfunction
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Event Description
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It was reported that after three days of intra-aortic balloon (iab) therapy, the sensor pressure showed an abnormal value of ap200 or higher.The waveform resembled the waveform of the internal pressure of the iab.There was no improvement after unplugging and reconnecting the sensor connector.Therapy was continued with the ecg trigger.Pressure information was externally input from another monitor.The iab was removed after six days of therapy.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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Occupation: clinical engineer.Event site postal code: (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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N/a.
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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 and between the catheter and the sheath.The extender tubing was also retuned.A kink was observed on the catheter tubing approximately 55.1cm from iab tip.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.A sensor output test was performed and the sensor was found to be within specification.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.The reported events cannot be confirmed by the evaluation.A 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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Search Alerts/Recalls
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