MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 6F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER AND HARDSHELL VEN. RES; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number IN00103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Death (1802)

Event Date 11/25/2016

Event Type  malfunction  

Manufacturer Narrative

Patient identifier was not provided.The complained inspire 6f oxygenator 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 involved device is similar to inspire 6f oxygenator catalog number 050715, which is distributed in the usa, for which the device identifier is (b)(4).The iinspire 6f oxygenator was a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone oxygenator (catalog number 050715) is registered in the usa (510(k) number: k130209).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 6f hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).Follow up information from the customer clarified that this case involved multiple surgeries.The first planned surgery started at 16:12 was followed by two other surgeries, which were not planned.The third surgery was when the event occurred, and was initiated at 22:50 with the same circuit and equipment used during the previous two.The condition of the patient was reported as being extremely critical even before starting the second procedure.During the third ecc, the surgeon reported the presence of hemolytic foam mixed together with bubbles in the aortic cannula.According to the perfusionist, the reservoir of the inspire 6f was never emptied and no air was ever seen in the tubing of the circuit.The circuit and the equipment were changed out following the observation.About 10 minutes after the change-out, the patient died due to a cardiac arrest.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 ongoing.A follow-up report will be sent when the investigation will be completed.

Event Description

Sorin group (b)(4) received a report that a massive gaseous embolism was observed in the cannula near the superior vena cava a few minutes into the ecc procedure.An inspire 6f hollow fiber oxygenator was used during the procedure.The customer reported that the patient expired.

Manufacturer Narrative

(b)(4).Sorin group (b)(4) manufactures the inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).(b)(4).The device was returned to sorin group (b)(4) for investigation.Visual inspection did not identify any holes, damage to the net of venous return filter, or cracks in the body of the oxygenator that may have enabled air enter in the blood path were identified.The returned device was assembled in a simple circuit and simulated use testing was performed for 2 hours while monitoring for potential bubble formation using a bubble sensor mounted at the exit of the oxygenator.No bubble alarm was triggered during this testing.The oxygenator behaved as expected.A dhr review did not reveal any relevant information potentially related to the reported event.The lot of the oxygenator was released according to specification and this lot of the oxygenator has not been involved in any other similar events.The claimed oxygenator performed according to product specification.No causality between the device and the reported event could be established.As the event does not appear ascribable to any device malfunction and sorin group (b)(4) is not aware of any other cases of air delivery to the patient in the last 12 months, no corrective action is deemed necessary.Sorin group (b)(4) will keep monitoring the market for similar events.

• Brand Name: INSPIRE 6F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER AND HARDSHELL VEN. RES
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (modena)
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (modena), italy 41037 ; IT 41037
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6202624
• MDR Text Key: 63227992
• Report Number: 9680841-2016-00521
• 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: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2019
• Device Catalogue Number: IN00103
• Device Lot Number: 1608010082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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: 78 YR
• Patient Weight: 65