• 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 S.R.L. INSPIRE 6F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER AND HARDSHELL VEN. 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 S.R.L. INSPIRE 6F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER AND HARDSHELL VEN. RES OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINSPIRE 6F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER AND HARDSHELL VEN. RES
Type of DeviceOXYGENATOR, 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 Key6202624
MDR Text Key63227992
Report Number9680841-2016-00521
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
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 03/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/02/2019
Device Catalogue NumberIN00103
Device Lot Number1608010082
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2016
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: 12/23/2016 Patient Sequence Number: 1
-
-