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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOT OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA SRL INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOT OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number IN00269
Device Problems Increase in Pressure (1491); Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/07/2016
Event Type  No Answer Provided  
Manufacturer Narrative
The complained inspire 8f hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir was a non-sterile component assembled into a sterile convenience pack that is not distributed in the usa. The catalog number, lot number, and expiration date refer to the sterile finished product into which the oxygenator was assembled. As the sterile finished product is not distributed in usa, there is no unique identifier (udi) number. However, the inspire 8f is similar to the inspire 8f oxygenator (catalog number 050716), which is distributed in the usa, for which the device identifier is (b)(4). The inspire 8f hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir was a non-sterile component assembled into a convenience pack that is not distributed in the usa. The stand alone oxygenator (catalog number 050716) is registered in the usa (510(k) number: k130433). 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 inspire 8f hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). On (b)(6) 2016, sorin group (b)(4) was notified that the user facility had submitted a report to the local competent authority. This medwatch report is being filed in response to this action. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The device was returned to sorin group (b)(4) for investigation and has been sent for decontamination. The investigation is on-going. A follow-up report will be sent when the investigation will be completed.
 
Event Description
Sorin group (b)(4) received a report of poor gas exchange performance of the inspire 8f hollow fiber oxygenator at the end of the procedure. The trans-membrane pressure was reported to have slowly increased during the procedure. The oxygenator was used for the rest of the case and the patient was intubated and transferred to the intensive care unit upon completion of the procedure. Subsequent information from the customer confirmed that there was no consequence to the patient.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the inspire 8f hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir. The incident occurred in (b)(6). The pump sheet for the event was sent to sorin group (b)(4) for evaluation. The data was closely reviewed and the transmembrane pressure values were analyzed with the help of a mathematical prediction model. The analysis confirmed that the transmembrane pressure values recorded during the event were above the expectations. Such a result is ascribable to clotting phenomenon. Accordingly, visual inspection of the returned oxygenator found massive clotting in the blood path and in the integrated arterial filter of the oxygenator. Sorin group (b)(4) has concluded that the most probable root cause of the clotting increase is a combination of multiple triggering factors, including interaction between the patient characteristic and the clinical procedure. Although the rate of occurrence for this type of event is very low with respect to the total quantity of devices distributed, sorin group (b)(4) has initiated a capa project to evaluate the material and device geometry interaction for cardiac bypass procedures.
 
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Brand NameINSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOT
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA SRL
strada statale 12 nord, 86
miradola (modena)
Manufacturer (Section G)
SORIN GROUP ITALIA S.R.L.
strada statale 12 nord, 86
mirandola (modena) 41037
IT 41037
Manufacturer Contact
joan cesar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6079089
MDR Text Key59221682
Report Number9680841-2016-00513
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue NumberIN00269
Device Lot Number1606290056
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/25/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2016
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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