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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 6 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA S.R.L. INSPIRE 6 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number IN00631
Device Problem Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2016
Event Type  No Answer Provided  
Manufacturer Narrative
The complained inspire 6 oxygenator (catalog number 03706, lot number 1602290132) is a non-sterile unit that was assembled into a convenience pack that is not distributed in the usa. The item, lot number and expiration date provided refer to the convenience pack. As the convenience pack is not distributed in the usa, the udi is not applicable. The inspire 6 oxygenator is similar to the oxygenator 050717, which is distributed in the usa, for which the device identifier is (b)(4). The complained inspire 6 oxygenator was assembled into a convenience pack that is not distributed in the usa, but it is similar to the inspire 6 oxygenator 050717, which is distributed in the usa (510(k) number: k121909). The date of manufacture provided refers to the manufacture date of the convenience pack into which the complained oxygenator was assembled. Sorin group (b)(4) manufactures the inspire 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy 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. A follow-up report will be sent when the investigation has been completed. (b)(4).
 
Event Description
Sorin group (b)(4) received a report that the po2 levels of the inspire 6 oxygenator were detected to be very low while at 100% fio2 near the end of the procedure. The physician elected to use an artificial respirator and not change out the oxygenator. There was no report of patient injury.
 
Manufacturer Narrative
(b)(4). Sorin group (b)(4) manufactures the inspire 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir. The incident occurred in (b)(6). (b)(4). The complained oxygenator was returned to sorin group (b)(4) and subjected to simulated used testing. The oxygenator was tested both according to relevant iso standard and in a way that simulated the use condition. Both functional tests showed that the oxygenator performed as expected. Based on the investigation results, the event does not appear to be ascribable to a device malfunction. The most probable root cause of the event is multi-factorial including interaction with clinical procedure and patient. As no device malfunction could be identified and the frequency of this kind of event is very low (b)(4), no corrective action is necessary. Sorin group (b)(4) will continue to monitor for trends related to this type of issue.
 
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Brand NameINSPIRE 6 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY 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) 41037
IT 41037
Manufacturer Contact
joan ceasar
14401 w 65th way
arvada, CO 80004
2812287260
MDR Report Key6151669
MDR Text Key61723357
Report Number9680841-2016-00518
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 02/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberIN00631
Device Lot Number1603290046
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/11/2016
Device Age7 MO
Event Location No Information
Date Manufacturer Received01/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
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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