Model Number CVDPTA |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2022 |
Event Type
malfunction
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Event Description
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It was reported that air injection was observed while an edwards lifesciences dpt was used with bayer avanta injection system, a contrast injection device, during use.The event occurred to the left coronary artery when contrast medium was injected to a male patient.It is unknown whether the dpt functioned properly.There were no patient complications reported.
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Manufacturer Narrative
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The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation when received.The lot number was not provided thus a device history record was not reviewed.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
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Manufacturer Narrative
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Additional information was received by the sales rep.The contrast was injected through a catheter located on the left and right coronary arteries.A dpt was connected to an arterial line and the pressure was monitored by a polygraph.Air was introduced into the left coronary artery of the patient.Air was imaged and the patient experienced ventricular fibrillation.The customer stated that the air was supposed to be introduced from the connection between ava 500 mpat, a multi patient disposable set, and ava 500 spat l, a single patient disposable set.The customer confirmed the use of ecmo for the patient.The customer claimed that they could not deny the possibility that the dpt might have been involved in the event, as they were not completely sure if the air was injected from bayer avanta injection system.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
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Manufacturer Narrative
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The reported event of leakage issue was not able to be confirmed.As received, all connections appeared tight.No visible defect or damage was observed from the unit during visual examination.No leakage was observed from the kit during leak test.Dpt zeroed and sensed pressure accurately on pressure monitor.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
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Search Alerts/Recalls
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