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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA S.R.L. INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 03704
Device Problems Low Readings (2460); Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/10/2017
Event Type  malfunction  
Manufacturer Narrative
The complained inspire 6f hollow fiber oxygenator with integrated arterial filter is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa. The expiration date refers to the sterile finished product into which the oxygenator was assembled. The unique identifier (udi) number of the sterile sterile convenience pack is: (b)(4). The age of the device was calculated as the time elapsed from device sterilization and the date of event. (b)(4). The complained inspire 6f hollow fiber oxygenator with integrated arterial filter is a non-sterile component assembled into a convenience pack that is distributed in the usa. The stand alone oxygenator (catalog number 050702) 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. The incident occurred in (b)(6). Per exemption number (b)(4), sorin group (b)(4). Is submitting the report for both sorin group (b)(4) (manufacturer) and (b)(4). (importer). 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 the arterial gas (oxygen) levels were low during a procedure. The inspire 6f oxygenator was changed out to resolve the issue. On (b)(6) 2017, sorin group (b)(4) received a user medwatch report (mw5067887) regarding this event. The report stated that the patient's vital signs and levels remained constant throughout the procedure and that no residual effects or complications were noted post procedure.
 
Manufacturer Narrative
(b)(4). The involved oxygenator was returned to sorin group (b)(4) for investigation. Simulated use testing was performed in standard conditions while monitoring gas exchange performances. The testing showed that the oxygenator performed according to product specifications and no failure could be reproduced. The manufacturing record for the involved device was reviewed and the oxygenator was found to have met the manufacturer's specifications upon release. The reported lot has not been involved in other similar complaints. As the issue could not be reproduced, the root cause was not identified and corrective actions were not determined.
 
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Brand NameINSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
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 (modena) 41037
IT 41037
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6394281
MDR Text Key69575577
Report Number9680841-2017-00005
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 05/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Catalogue Number03704
Device Lot Number1609070141
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/10/2017
Device Age4 MO
Event Location No Information
Date Manufacturer Received04/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2016
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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