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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Manufacturer Narrative
The issue occurred prior to any patient involvement. The inspire 8f m 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 m oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa. The standalone 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 m oxygenator. The incident occurred in (b)(6), united states. The involved device has been requested for return to sorin group (b)(4) for investigation. The device has not yet been received in sorin group (b)(4). If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Not yet received.
 
Event Description
Sorin group (b)(4) has received a report that, during set up of a circuit prior to a procedure, the perfusionist turned on the water flow to do the water leak test and found that water filled the tubing circuit and reservoir of the inspire oxygenator. The issue occurred prior to any patient involvement.
 
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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
Manufacturer (Section G)
SORIN GROUP ITALIA SRL
strada statale 12 nord, 86
mirandola 41037
IT 41037
Manufacturer Contact
enrico greco
14401 w 65th way
arvada, CO 80004
MDR Report Key12867866
MDR Text Key283255109
Report Number9680841-2021-00033
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
Type of Report Initial,Followup
Report Date 03/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03705
Device Lot Number2106250003
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2021
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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