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U.S. Department of Health and Human Services

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

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SORIN GROUP ITALIA SRL SORIN LIFEKIT D905 EOS ECMO OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 05469
Device Problem Fluid 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.
 
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Brand NameSORIN LIFEKIT D905 EOS ECMO
Type of DeviceOXYGENATOR, 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 Key12632482
MDR Text Key281923778
Report Number9680841-2021-00028
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
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 Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05469
Device Lot Number2009090064
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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