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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL EOS PMP, EOS PMP INTEGRATED OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA SRL EOS PMP, EOS PMP INTEGRATED OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 03486
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2021
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided. The dideco eos ecmo oxygenator is a non-sterile device assembled into a sterile convenience pack (item c24520; lot 2011300110) that is not distributed in the usa. The expiration date refers to the sterile finished product into which the oxygenator was assembled. As the sterile convenience pack is not distributed in usa, the udi number is not applicable. The complained dideco eos ecmo oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa. The product item 03486 - dideco eos ecmo is not distributed in the usa and it is similar to the eos pmp, eos pmp integrated item 050576, which is distributed in the usa (510(k) number: k150489). The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled. Sorin group (b)(4) manufactures the dideco eos ecmo oxygenator. The incident occurred in be (b)(6). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The involved device has been requested for return to sorin group (b)(4) for investigation. If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
 
Event Description
Sorin group (b)(4) has received a report that, at the begin of an ecmo procedure to a covid patient, blood leakage from blood compartment to water compartment. The medical team elected to change out the oxygenator. There is no report of any patient injury.
 
Manufacturer Narrative
Livanova received a report regarding a blood leak from the hansen connectors of the water compartment of an eos ecmo oxygenator. The oxygenator was replaced. There is no report of any patient injury. The oxygenator was received a livanova facility for investigation. Initial visual inspection did not identify any obvious damage or non-conformity. To investigate the claimed issue, the blood compartment of the oxygenator was filled with water and pressurized. The leak test could reproduce the leak from the hansen connector from water in the blood compartment thus confirming the presence of a communication (damage/hole) in the metal sheet between water and blood compartments. The oxygenator was autopsied, and the metal sheet was sectioned to identify the point where the sheet was damaged. The hole was identified in the correspondence of a metal sheet folding. No trace of corrosion or metal degradation was found in the damaged area. Dhr of the complained eos ecmo did not identify any issue. All (100%) of the units are leak tested during manufacturing: the complained oxygenator has successfully passed the leak test. Review of the livanova complaint database did not identify any other similar event relevant to the lot of oxygenator or heat exchanger module thus excluding any systematic issue. To investigate the possible root cause of communication between water and blood compartments, the (b)(4) was opened. Results of the investigation suggested the most probable root causes are residual processing stress associated to cold metal sheet deformation combined by corrosion, presence of sand residue after sanding process and degradation of compacting surface. Despite the risk is acceptable and the frequency of this type of event is low (incredible), to further decrease the occurrence, livanova has planned to start to treat metal sheet of eos ecmo&pmp oxygenators with primer to improve the corrosion resistance. The validation activities have been completed and implementation of this action is planned by end 2021. Livanova investigation could not identify any specific root cause. Based on the above, it cannot be ruled out that most probable root cause is a manufacturing damage that is not detectable during manufacturing test. The damage evolves after device release with the contribution of some other factors such as corrosion, residual sand and degradation. Livanova has identified action to improve the corrosion resistance of the metal sheet. As no specific root cause was identified and the probability is acceptable, no other action was deemed necessary. Livanova will maintain monitoring the market for similar events.
 
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Brand NameEOS PMP, EOS PMP INTEGRATED
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA SRL
strada statale 12 nord, 86
mirandola, modena
Manufacturer (Section G)
SORIN GROUP ITALIA
strada statale 12 nord, 86
mirandola, modena 41037
IT 41037
Manufacturer Contact
enrico greco
14401 w 65th way
arvada, CO 80004
MDR Report Key11776993
MDR Text Key265359259
Report Number9680841-2021-00011
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeBE
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 06/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03486
Device Lot Number2011170050
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2020
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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