MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 8 START P HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050712

Device Problems Low Readings (2460); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The inspire 8 start p oxygenator (catalog number 050712, lot 1602050162) is not distributed in the usa, therefore 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).F the age of the device was calculated as the time elapsed from device sterilization and the date of event.(b)(4).Pma 510(k): 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 p hollow fiber oxygenator with integrated hardshell reservoir.The incident occurred in (b)(6).(b)(4).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 received, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) received a report that low oxygen values were found in the inspire 8 start p hollow fiber oxygenator when the perfusionist analyzed a blood gas parameter following aortic cross clamp.The perfusionist quickly checked the entire circuit and decided to change to a new membrane oxygenator.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(6) manufactures the inspire 8 start p hollow fiber oxygenator with integrated hardshell reservoir.The incident occurred in (b)(6).Per exemption number e2016005, sorin group (b)(6).Is submitting the report for both sorin group (b)(6) (manufacturer) and livanova usa., inc.(importer).The involved device was returned to sorin group (b)(6) for investigation.During visual inspection, no visible defects were noted.A gas exchange performance test was conducted per iso 7199 standard blood conditions.No device malfunction was been identified during this testing.The involved device was found to be conforming to the manufacturer specifications.As the issue could not be reproduced, a root cause was not determined.However, the most likely root cause is associated to the clinical practice.

• Brand Name: INSPIRE 8 START P HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (mo)
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: joan caesar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6632128
• MDR Text Key: 77452931
• Report Number: 9680841-2017-00019
• 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: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2019
• Device Catalogue Number: 050712
• Device Lot Number: 1602050162
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/11/2017
• Device Age: 16 MO
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2016
• 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