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U.S. Department of Health and Human Services

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

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SORIN GROUP ITALIA SRL INSPIRE 8F HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 03705
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2019
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided. The inspire 8f hollow fiber oxygenator 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 convenience pack is (((b)(4)). The involved inspire 8f hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa. The stand-alone oxygenator (catalog number 050703) is also registered in the usa (510(k) number: k180448). 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 8f hollow fiber oxygenator. The incident occurred in (b)(4); united states. The involved device has been requested for return to sorin group (b)(4) for investigation and it has not yet been 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)(6) has received a report that, during a procedure, red tinged water was noticed in the heater cooler lines of the inspire 8f oxygenator. The medical team elected to complete the procedure. There is not report of any patient injury.
 
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Brand NameINSPIRE 8F 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
strada statale 12 nord, 86
mirandola, modena 41037
IT 41037
Manufacturer Contact
enrico greco
14401 w 65th way
arvada, CO 80004
MDR Report Key9568215
MDR Text Key219775637
Report Number9680841-2020-00002
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 04/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Catalogue Number03705
Device Lot Number1909060035
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 Received04/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/28/2019
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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