Patient information was not provided.
The expiration date refers to the sterile finished product.
The complained eos ecmo oxygenator (catalog number 05469 - sorin lifekit d905 eos ecmo, lot 2009090064) is not distributed in the usa, therefore the udi is not applicable.
The oxygenator item 05469 is similar to the item 050576 - eos pmp, eos pmp integrated oxygenator, which is distributed in the usa, for which the device identifier is (b)(4).
The product item 05469 - sorin lifekit d905 eos ecmo is not distributed in the usa, but it is similar to the item 050576 - eos pmp, eos pmp integrated oxygenator, which is distributed in the usa (510(k) number: k150489).
The device manufacture date refers to manufacture date of the sterile, finished oxygenator.
Sorin group (b)(4) manufactures the item 05469 - sorin lifekit d905 eos ecmo.
The incident occurred in (b)(6).
Sorin group (b)(4) has not been informed if the complained oxygenator is available for investigation.
During follow up information with the customer livanova has been informed that: leak was detected when patient was connected to the hlm.
There is no impact on the patient, the eos ecmo oxygenator has been disposed.
Eos ecmo oxygenator has been primed for less that 24 hours.
If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
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