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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number IN00236
Device Problem Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2016
Event Type  No Answer Provided  
Manufacturer Narrative
Patient identifier, age and sex were not provided. The inspire 8m oxygenator was a non-sterile device assembled into a sterile convenience pack (item in00236). The catalog number, lot number, expiration date and udi number refer to the convenience pack. The complained inspire 8m oxygenator was a non-sterile device assembled into a convenience pack that is not distributed in the usa. The oxygenator is also distributed in the usa as a stand alone sterile device (510(k) number: k130433). Sorin group (b)(4) manufactures the inspire 8m oxygenator. The incident occurred in (b)(6). (b)(4). Sorin group (b)(4) received a report that, during cec, the fio2 levels increased from 75 to 100%, but the po2 would not rise above 19 kpa. During re-warming, the surgeon elected to ventilate the patient and continue monitoring. There was no report of patient injury. The oxygenator will not be returned to sorin group (b)(4) for further analysis, as the device was inadvertently discarded by the customer. The investigation is on-going. A follow-up report will be sent when the investigation will be completed. Device discarded by user.
 
Event Description
Sorin group (b)(4) received a report that, during cec, the fio2 levels increased from 75 to 100%, but the po2 would not rise above 19 kpa. During re-warming, the surgeon elected to ventilate the patient and continue monitoring. There was no report of patient injury.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the inspire 8m oxygenator. 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 cec, the fi02 levels increased from 75 to 100%, but the po2 would not rise above 19 kpa. During re-warming, the surgeon elected to ventilate the patient and continue monitoring. There was no report of patient injury. The complained device was discarded by the customer and was not available for return to sorin group (b)(4). The pump record was provided for analysis, which revealed that the po2 recorded values decreased 1 hour and 30 minutes after the start of the procedure. An inspire 8m oxygenator from a different lot was pulled from inventory and tested in similar conditions to those described in the pump record. Simulated use testing did not reproduce the reported issue and unit behaved as expected. The manufacturing record for the involved device was reviewed and the oxygenator was found to have met specifications upon release. As the complained device was not returned and the issue could not be reproduced on the sample oxygenator pulled from inventory, a root cause could not be determined and no corrective actions were identified. Sorin group (b)(4) will continue to monitor for trends related to this type of issue. Device discarded by customer.
 
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Brand NameINSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY 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
via statale 12 nord, 86
mirandola (mo), italy 41037
IT 41037
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5828193
MDR Text Key50617223
Report Number9680841-2016-00494
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUK
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 06/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Catalogue NumberIN00236
Device Lot Number1601120062
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 Received08/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2016
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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