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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL OXYGENATOR, CARDIOPULMONARY BYPASS INSPIRE 6 PHISIO OXY MODULE WITH INTEGRATED PHISIO HARD SHELL SINGLE CHAMBER RE

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SORIN GROUP ITALIA SRL OXYGENATOR, CARDIOPULMONARY BYPASS INSPIRE 6 PHISIO OXY MODULE WITH INTEGRATED PHISIO HARD SHELL SINGLE CHAMBER RE Back to Search Results
Catalog Number 03706
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2019
Event Type  malfunction  
Manufacturer Narrative
No patient information has been provided. The inspire 6 phisio oxygenator is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa. The lot of the sterile convenience pack is unknown. The expiration date and the unique identifier (udi) are unknown. The involved inspire 6 phisio oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa. The standalone oxygenator (catalog number 050700) is also registered in the usa (510(k) number: k180448). The lot of the sterile convenience pack is unknown. The device manufacture date refers is unknown. Sorin group (b)(4) manufactures the inspire 6 phisio oxygenator. The incident occurred in (b)(6) (united states). The involved device has been requested for return to sorin group (b)(4) for investigation but not yet received. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not yet returned.
 
Event Description
Sorin group (b)(4) has received a report that, 30 minutes after the bypass was begun, a leak near the temperature port of the inspire 6 oxygenator was identified. The medical team elected to change out the oxygenator. The change out took 5 minutes. The procedure was completed with no issue. There is not report of any patient injury.
 
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Brand NameOXYGENATOR, CARDIOPULMONARY BYPASS
Type of DeviceINSPIRE 6 PHISIO OXY MODULE WITH INTEGRATED PHISIO HARD SHELL SINGLE CHAMBER RE
Manufacturer (Section D)
SORIN GROUP ITALIA SRL
strada statale 12 nord, 86
mirandola, modena
Manufacturer (Section G)
SORIN GROUP ITALIA SRL
strada statale 12 nord, 86
mirandola, modena 41037
IT 41037
Manufacturer Contact
enrico greco
14401 w 65th way
arvada, CO 80004
MDR Report Key9437883
MDR Text Key208577018
Report Number9680841-2019-00041
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 Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2019
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03706
Device Lot Number1906040008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/26/2020
Was Device Evaluated by Manufacturer? Yes
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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