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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8M HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA SRL INSPIRE 8M HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 03707
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2019
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided. The inspire 8 hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack that is not distributed in the usa. The lot of the oxygenator was used by three batches: pr1600028549, pr1600028766 and pr1600028994. As the lot of the sterile finished convenience pack into which the oxygenator was assembled is unknown, the expiration date of the product is unknown. As the sterile is not distributed in usa, the udi number is not applicable. The complained inspire 8 hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa. The stand-alone oxygenator (catalog number 050701) is registered in the usa (510(k) number: k180448). The lot of the oxygenator was used by three batches: pr1600028549, pr1600028766 and pr1600028994. As the lot of the sterile finished convenience pack into which the oxygenator was assembled is unknown, the expiration date of the product is unknown, the device manufacture date is unknown. Sorin group (b)(4) manufactures the inspire 8 hollow fiber oxygenator. The incident occurred in (b)(6). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The involved device was disposed, and it is not available for investigation. If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report. Device not available.
 
Event Description
Sorin group (b)(4) has received a report that, during a procedure, a leak was identified from a crack by the inspire 8 oxygenator. The medical team elected to administer antibiotic to the patient. There is not report of any patient injury.
 
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Brand NameINSPIRE 8M HOLLOW FIBER OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
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 Key9563680
MDR Text Key196290314
Report Number9680841-2020-00001
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeAS
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 04/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number03707
Device Lot Number1907180004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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