EDWARDS LIFESCIENCES AVID THIN-FLEX DUAL STAGE 29/37F VENOUS DRAINAGE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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Model Number TF293702A |
Device Problems
Incorrect Measurement (1383); Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Out of box failures can result from many different product malfunctions, some less serious than others.If the malfunction occurring out of box would have been reportable had it occurred in the patient, then it should be reportable.This should be based on the actual failure mode or non-conformance.In this case the depth markers of the cannula provide a reference for correct positioning of the cannula.If the cannulas were used, potential for serious injury is not remote.The device was not returned for evaluation, as device request is ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
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Event Description
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It was reported that 18 units of dual-stage venous cannulas markings are off.As reported, it appeared to the surgeon that the markings were slightly off, but the perfusionist did not see any differences.The case proceeded in normal fashion.
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Event Description
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Per imaging evaluation report of tf293702a dual-stage venous cannula's markings are off was unable to be confirmed.Two images were provided.First image showed a cannula from reported model on top of the tyvek lid from reported model and lot number.Second image showed two cannulas inside the pouch.Location of depth markers was not able to be confirmed.
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Manufacturer Narrative
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H10: additional manufacturer narrative: updated sections d4 (expiration date), h4, h6 (type of investigation, investigation findings, investigation conclusions).Per image evaluation, no identifiable non-conformances were observed.The reported complaint is not confirmed, and an edwards defect is not confirmed.No injury was indicated as a result of this event.Attempts have been made to obtain product for evaluation.No device was returned.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.H11: corrected data: corrected section h6 (device code).
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