• 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 SRL INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY 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 SRL INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 050712
Device Problems Fluid Leak (1250); Overfill (2404)
Patient Problems Blood Loss (2597); Patient Problem/Medical Problem (2688)
Event Date 09/13/2016
Event Type  Injury  
Manufacturer Narrative
Patient information was not provided. The complained inspire 8 start oxygenator (catalog number 050712, lot 1607140198), is a sterile device that is not distributed in the usa. As the product item 050712 is not distributed in the usa, the udi is not applicable. The oxygenator item 050712 is similar to the inspire 8 oxygenator 050714, which is distributed in the usa, for which the device identifier is (b)(4). The product item 050712 is not distributed in the usa, but it is similar to the inspire 8 oxygenator 050714, which is distributed in the usa (510(k) number: k130433). Sorin group (b)(4) manufactures the inspire 8 start hollow fiber oxygenator with integrated hardshell venous/cardiotomy 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 the reservoir of the inspire 8 oxygenator began gradually filling 30 minutes after starting the ecc case, right after circulation was stopped to initiate the cerebral perfusion. The arterial and venous lines were clamped, the vacuum was interrupted and the gas inlet line was disconnected. However, the reservoir kept filling up and blood began leaking from the upper part of the reservoir. To continue the procedure, the medical team elected to change out the entire system. The change-out took nearly 20 minutes and the patient was transfused 9 units of blood and transferred into intensive care. According to the perfusionists, the level of the water in the tank of the heater-cooler had decreased. At the present date, the patient has not been discharged from intensive care. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The device has been requested for return to sorin group (b)(4) for investigation. A follow-up report will be sent when the investigation has been completed. Device not yet returned to manufacturer.
 
Event Description
Sorin group (b)(4) received a report that the reservoir of the inspire 8 oxygenator began gradually filling 30 minutes after starting the ecc case, right after circulation was stopped to initiate the cerebral perfusion. The arterial and venous lines were clamped, the vacuum was interrupted and the gas inlet line was disconnected. However, the reservoir kept filling up and blood began leaking from the upper part of the reservoir. To continue the procedure, the medical team elected to change out the entire system. The change-out took nearly 20 minutes and the patient was transfused 9 units of blood and transferred into intensive care. According to the perfusionists, the level of the water in the tank of the heater-cooler had decreased. At the present date, the patient has not been discharged from intensive care.
 
Manufacturer Narrative
(b)(4) manufactures the inspire 8 start hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). The complained device was returned to sorin group (b)(4) for investigation and the water and blood compartments of the returned oxygenator module were leak tested. The blood compartment was filled and pressurized at 1. 5 bar (1. 5 times the maximum recommended pressure, per the instructions for use) for 30 minutes while monitoring for any leaks into the water compartment. No leaks were detected during this testing. A similar test was repeated at the water side. Again, no leaks were identified during this testing. In order to exclude blood clots occluding the potential leaking area, the water compartment was tested at 38°c for 2 hours and again at 20°c for another two hours. No leaks across the compartments were observed during this time. The reported issue was not reproduced and the unit behaved as expected. As the issue could not be reproduced, a root cause could not be determined and corrective actions were not identified. Sorin group (b)(4) has determined that the reported issue is not ascribable to an issue with the device. Sorin group (b)(4) will continue to monitor for trends related to this type of issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA SRL
strada statale 12 nord, 81
mirandola (modena)
Manufacturer (Section G)
SORIN GROUP ITALIA S.R.L.
strada statale 12 nord 86
mirandola (modena) 41037
IT 41037
Manufacturer Contact
joan ceasar
14401 w 65th way
arvada, CO 80004
2812287260
MDR Report Key6025990
MDR Text Key57293378
Report Number9680841-2016-00507
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 09/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/15/2019
Device Catalogue Number050712
Device Lot Number1607140198
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2016
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: 10/13/2016 Patient Sequence Number: 1
-
-