• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SORIN GROUP ITALIA ADULT MEMBRANE OXYGENATOR W/ INTEGRATED ARTERIAL FILTER & HARDSHELL VENOUS RES. OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameADULT MEMBRANE OXYGENATOR W/ INTEGRATED ARTERIAL FILTER & HARDSHELL VENOUS RES.
Type of DeviceOXYGENATOR, 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 Key5724842
MDR Text Key47390037
Report Number9680841-2016-00365
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
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 Received06/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberAB1481
Device Lot Number1603220152
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 Received07/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2016
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
-
-