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

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.

• Brand Name: INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOT
• Type of Device: OXYGENATOR, 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 Key: 6079089
• MDR Text Key: 59221682
• Report Number: 9680841-2016-00513
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2019
• Device Catalogue Number: IN00269
• Device Lot Number: 1606290056
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial