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Model Number CB4W67R15 |
Device Problem
Misassembled (1398)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/05/2016 |
Event Type
malfunction
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Manufacturer Narrative
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With the available information, medtronic cannot confirm or deny the root cause of this occurrence as no product has been returned to date.Medtronic's investigation is still in progress.
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Event Description
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Medtronic received information that after initiating extracorporeal membrane oxygenation (ecmo) support using a medtronic tubing pack, the customer observed very low patient blood pressure.After approximately seven minutes, the customer realized the red and blue labels on the tubing outside of the sterile field, did not coincide with the red blue labels on the inside of the sterile field that were connected to the arterial and venous cannula.The lines were clamped, tubing cut, and circuit re-connected the correct way.Patient blood pressure returned to normal and no adverse patient effects were reported.The product is not expected to return to medtronic for analysis.During priming of this circuit, the customer observed a leak from the 3/8 inch connector with blue tape.The customer cut the piece to replace it with another connector.While the leaking connector had blue tape present, the replacement connector did not.After the connector was replaced, priming was completed and ecmo initiated.
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Manufacturer Narrative
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Medtronic is pursuing additional information to clarify the official cause of patient death and confirm whether or not the medtronic product event caused or contributed to the patient outcome.Conclusion of medtronic investigation: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The root cause for this event could not be determined.Although the root cause could not be determined, the medtronic quality engineers implemented a simplified process for the tubing pack assembly as a preventative measure.
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Event Description
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Medtronic received information that during a procedure, the customer observed very low patient blood pressure for approximately 7 minutes.After 7 minutes, the customer realized the red and blue labels on the tubing in the clamshell outside the sterile field, did not coincide with the red and blue labels on the inside of the sterile field.The customer clamped the tubing, re-adjusted to ensure the red/blue orientation was correct, un-clamped the tubing and resumed ecmo support.The customer indicated the patient blood pressure returned to normal.The product is not expected to return to medtronic.After several more days on ecmo support, the patient ultimately expired on (b)(6) 2016.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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