MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050712

Device Problems Fluid/Blood Leak (1250); Overfill (2404)

Patient Problems Blood Loss (2597); Patient Problem/Medical Problem (2688)

Event Date 09/13/2016

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.The complained inspire 8 start oxygenator (catalog number 050712, lot 1607140198), is a sterile device that is not distributed in the usa.As the product item 050712 is not distributed in the usa, the udi is not applicable.The oxygenator item 050712 is similar to the inspire 8 oxygenator 050714, which is distributed in the usa, for which the device identifier is (b)(4).The product item 050712 is not distributed in the usa, but it is similar to the inspire 8 oxygenator 050714, which is distributed in the usa (510(k) number: k130433).Sorin group (b)(4) manufactures the inspire 8 start 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).Sorin group (b)(4) received a report that the reservoir of the inspire 8 oxygenator began gradually filling 30 minutes after starting the ecc case, right after circulation was stopped to initiate the cerebral perfusion.The arterial and venous lines were clamped, the vacuum was interrupted and the gas inlet line was disconnected.However, the reservoir kept filling up and blood began leaking from the upper part of the reservoir.To continue the procedure, the medical team elected to change out the entire system.The change-out took nearly 20 minutes and the patient was transfused 9 units of blood and transferred into intensive care.According to the perfusionists, the level of the water in the tank of the heater-cooler had decreased.At the present date, the patient has not been discharged from intensive care.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The device has been requested for return to sorin group (b)(4) for investigation.A follow-up report will be sent when the investigation has been completed.Device not yet returned to manufacturer.

Event Description

Sorin group (b)(4) received a report that the reservoir of the inspire 8 oxygenator began gradually filling 30 minutes after starting the ecc case, right after circulation was stopped to initiate the cerebral perfusion.The arterial and venous lines were clamped, the vacuum was interrupted and the gas inlet line was disconnected.However, the reservoir kept filling up and blood began leaking from the upper part of the reservoir.To continue the procedure, the medical team elected to change out the entire system.The change-out took nearly 20 minutes and the patient was transfused 9 units of blood and transferred into intensive care.According to the perfusionists, the level of the water in the tank of the heater-cooler had decreased.At the present date, the patient has not been discharged from intensive care.

Manufacturer Narrative

(b)(4) manufactures the inspire 8 start 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).The complained device was returned to sorin group (b)(4) for investigation and the water and blood compartments of the returned oxygenator module were leak tested.The blood compartment was filled and pressurized at 1.5 bar (1.5 times the maximum recommended pressure, per the instructions for use) for 30 minutes while monitoring for any leaks into the water compartment.No leaks were detected during this testing.A similar test was repeated at the water side.Again, no leaks were identified during this testing.In order to exclude blood clots occluding the potential leaking area, the water compartment was tested at 38°c for 2 hours and again at 20°c for another two hours.No leaks across the compartments were observed during this time.The reported issue was not reproduced and the unit behaved as expected.As the issue could not be reproduced, a root cause could not be determined and corrective actions were not identified.Sorin group (b)(4) has determined that the reported issue is not ascribable to an issue with the device.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.

• Brand Name: INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 81; mirandola (modena)
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord 86; mirandola (modena) 41037 ; IT 41037
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6025990
• MDR Text Key: 57293378
• Report Number: 9680841-2016-00507
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2019
• Device Catalogue Number: 050712
• Device Lot Number: 1607140198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other