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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 8 START P HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA S.R.L. INSPIRE 8 START P HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 050712
Device Problems Low Readings (2460); Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/20/2017
Event Type  malfunction  
Manufacturer Narrative
Sorin group (b)(6) manufactures the inspire 8 start p hollow fiber oxygenator with integrated hardshell reservoir. The incident occurred in (b)(6). Per exemption number e2016005, sorin group (b)(6). Is submitting the report for both sorin group (b)(6) (manufacturer) and livanova usa. , inc. (importer). The involved device was returned to sorin group (b)(6) for investigation. During visual inspection, no visible defects were noted. A gas exchange performance test was conducted per iso 7199 standard blood conditions. No device malfunction was been identified during this testing. The involved device was found to be conforming to the manufacturer specifications. As the issue could not be reproduced, a root cause was not determined. However, the most likely root cause is associated to the clinical practice.
 
Manufacturer Narrative
Patient information was not provided. The inspire 8 start p oxygenator (catalog number 050712, lot 1602050162) is not distributed in the usa, therefore 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). F the age of the device was calculated as the time elapsed from device sterilization and the date of event. (b)(4). Pma 510(k): 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 p hollow fiber oxygenator with integrated hardshell reservoir. The incident occurred in (b)(6). (b)(4). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The involved device has been requested for return to sorin group (b)(4) for investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Sorin group (b)(4) received a report that low oxygen values were found in the inspire 8 start p hollow fiber oxygenator when the perfusionist analyzed a blood gas parameter following aortic cross clamp. The perfusionist quickly checked the entire circuit and decided to change to a new membrane oxygenator. There was no report of patient injury.
 
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Brand NameINSPIRE 8 START P HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L.
strada statale 12 nord, 86
mirandola (mo)
Manufacturer (Section G)
SORIN GROUP ITALIA S.R.L.
strada statale 12 nord, 86
mirandola 41037
IT 41037
Manufacturer Contact
joan caesar
14401 w 65th way
arvada, CO 80004
2812287260
MDR Report Key6632128
MDR Text Key253678603
Report Number9680841-2017-00019
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 08/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/05/2019
Device Catalogue Number050712
Device Lot Number1602050162
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/11/2017
Device Age16 MO
Event Location No Information
Date Manufacturer Received07/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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