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

Catalog Number 03707

Device Problems Increase in Pressure (1491); Pressure Problem (3012)

Patient Problems Death (1802); Heart Failure (2206)

Event Date 02/16/2017

Event Type  Death  

Manufacturer Narrative

Patient identifier was not provided.The complained inspire 8m oxygenator was a non-sterile component assembled into a sterile convenience pack 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 finished product is not distributed in usa, there is no unique identifier (udi) number.However, the involved device is similar to inspire 8m oxygenator catalog number 050714, which is distributed in the usa, for which the device identifier is (b)(4).(b)(4).The inspire 8m oxygenator was a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone oxygenator (catalog number 050714) 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 8m hollow fiber oxygenator.(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 a patient arrived at the or for emergency surgery of aorta dissection following cardiac arrest.Approximately 10 minutes after initiating bypass, the pressure of the inspire 8m oxygenator rapidly increased and lead to a complete pump stop.The patient was taken off bypass and several minutes later, the heart stopped and patient expired.

Manufacturer Narrative

(b)(4) manufactures the inspire 8m hollow fiber oxygenator.The incident occurred in (b)(6).(b)(4).The involved device was returned to sorin group (b)(4) for investigation.A thorough investigation of the returned device was unable to replicate the reported failure.The device performed as expected, including pressure drop.Based on the information provided, the reported increase of pressure was originated downstream from the oxygenator, which would mean the device was not the cause.As the issue was not reproduced, a root cause was not determined.

• Brand Name: INSPIRE 8 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 (mo) 41037 ; IT 41037
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6408856
• MDR Text Key: 70060121
• Report Number: 9680841-2017-00009
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2019
• Device Catalogue Number: 03707
• Device Lot Number: 1611100003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/17/2017
• Device Age: 2 MO
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• 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): Death
• Patient Age: 52 YR
• Patient Weight: 73