MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL SORIN LIFEKIT D905 EOS ECMO OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 05469

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

Event Description

Sorin group (b)(4) has received a report that, during support, blood was identified in exiting from water connectors. There is no report of any patient injury.

Manufacturer Narrative

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.

• Brand Name: SORIN LIFEKIT D905 EOS ECMO
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 12632482
• MDR Text Key: 281923778
• Report Number: 9680841-2021-00028
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 05469
• Device Lot Number: 2009090064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial