MAUDE Adverse Event Report: SORIN GROUP ITALIA ADULT MEMBRANE OXYGENATOR W/ INTEGRATED ARTERIAL FILTER & HARDSHELL VENOUS RES. OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number AB1481

Device Problems Device Operational Issue (2914); Infusion or Flow Problem (2964)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Brain Injury (2219)

Event Date 05/18/2016

Event Type  Death  

Manufacturer Narrative

Patient identifier was not provided. The synthesys oxygenator was assembled into a customized circuit (item ab1481) that is not distributed in the usa, but the oxygenator is similar to the synthesis oxygenator that is distributed in the usa (510(k)number: k120185). Sorin group (b)(4) manufactures the adult membrane oxygenator with integrated arterial filter and hardshell venous 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, during a procedure involving an adult membrane oxygenator with integrated arterial filter and hardshell venous reservoir, a sudden overflow of the venous and arterial systems occurred and air was observed in both lines. The customer reported that this occurred while the cardiotomy tank was filled above the level sensor. Due to patient hypotension, steps were taken for resuscitation including direct cardiac massage. The system was changed out for a second system, which worked flawlessly for the duration of the procedure. On may 23, 2016, sorin group (b)(4) was notified that the patient had suffered a massive brain injury and died on (b)(6) 2016. Photographs taken by the customer and sent to sorin group (b)(4) show that the over-under valve on top of the reservoir of the oxygenator was occluded with two pieces of tape during the ecc procedure. This is contraindicated in the device instructions for use. Sorin group (b)(4) is currently attempting to obtain further clarification on the event from the customer. A review of the dhr for the oxygenator determined that the device passed all in process controls within the established specifications. The investigation is ongoing. A follow-up report will be sent when the investigation is complete. Device under seizure by hospital.

Event Description

Sorin group (b)(4) received a report that, during a procedure involving an adult membrane oxygenator with integrated arterial filter and hardshell venous reservoir, a sudden overflow of the venous and arterial systems occurred and air was observed in both lines. The customer reported that this occurred while the cardiotomy tank was filled above the level sensor. Due to patient hypotension, steps were taken for resuscitation including direct cardiac massage. The system was changed out for a second system, which worked flawlessly for the duration of the procedure. On may 23, 2016, sorin group (b)(4) was notified that the patient had suffered a massive brain injury and died on (b)(6) 2016.

Manufacturer Narrative

At the present date, the perfusion tubing system and involved oxygenator remain seized. Sorin group has made attempts to retrieve the disposable for investigation, however these attempts have not been successful. Sorin group (b)(4) manufactures the adult membrane oxygenator with integrated arterial filter and hardshell venous reservoir. The incident occurred in (b)(6). (b)(4). Sorin group (b)(4) received a report that, during a procedure involving an adult membrane oxygenator with integrated arterial filter and hardshell venous reservoir, a sudden overflow of the venous and arterial systems occurred and air was observed in both lines. The customer reported that this occurred while the cardiotomy tank was filled above the level sensor. Due to patient hypotension, steps were taken for resuscitation including direct cardiac massage. The system was changed out for a second system, which worked flawlessly for the duration of the procedure. On may 23, 2016, sorin group (b)(4) was notified that the patient had suffered a massive brain injury and died on (b)(6) 2016. Additional information received from the customer clarified that a mixture of air and blood was seen coming under pressure from the inferior vena cava. At the same time, both the venous line and the arterial line, up to the arterial cannula, were seen to contain air. The perfusionist also confirmed that the unit was primed and air was removed (de-bubbling) according to instructions for use (ifu). The level sensor was checked before the procedure and was found to be working properly. The level of blood inside the reservoir was stable throughout the procedure and no air was ever seen in the oxygenator. The peristaltic arterial pump was also checked before the procedure and was found to be occluded. The customer did not confirm whether or not a bubble sensor was in use during the procedure. Inspection of the photographic surveys and videos of the involved unit taken by a sorin group representative confirmed that the over/under pressure safety valve present on the top of the reservoir was occluded with two pieces of tape. This use is contraindicated in the ifu. Sorin group (b)(4) is not aware of any other cases of air delivery to the patient involving a synthesis oxygenator or the complained circuit. Sorin group (b)(4) has not received any additional information from the hospital relevant to the management of the ecc procedure and has not yet received the device for the investigation. As an investigation could not be performed, a root cause cannot be determined and no corrective actions can be identified. No further investigation is possible. Unit seized.

• Brand Name: ADULT MEMBRANE OXYGENATOR W/ INTEGRATED ARTERIAL FILTER & HARDSHELL VENOUS RES.
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo), 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (modena), italy 41037 ; IT 41037
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5724842
• MDR Text Key: 47390037
• Report Number: 9680841-2016-00365
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/28/2019
• Device Catalogue Number: AB1481
• Device Lot Number: 1603220152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/14/2016 Patient Sequence Number: 1