• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SORIN GROUP ITALIA SRL INSPIRE 8 HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 03703
Device Problem Increase in Pressure (1491)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2021
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided the inspire 8 m start hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack (item in00647, lot 2011090095) that is not distributed in the usa. The expiration date refers to the sterile finished product into which the oxygenator was assembled. As the sterile convenience pack is not distributed in usa, the udi number is not applicable. The complained inspire 8 start oxygenator is not distributed in the usa. The oxygenator inspire 8 start is similar to the oxygenator inspire 8 m (catalogue 050701), which is distributed in the usa, for which the device identifier is 08033178112260. Lot of the complained inspire 8 start oxygenator could not be identified. Possible lots are 2011030001 or 2011030001 or 2010160105 or 2010230. The complained inspire 8 start oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa. The stand alone inspire 8 start oxygenator is not distributed in the usa and is similar to the inspire 8 oxygenator (catalogue 050701) that is 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 8 start m 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 is not available for return to sorin group (b)(4) for investigation. Follow up with the customer clarified the following points: no oxygenation performance issue was reported. Blood flow rate pre-membrane was 5 lpm, post-membrane was 0. 5 lpm the pump sheet of the procedure is not available the low pressure occurred at the starting surgery, after clamping and before declamping medical team elected to change out the oxygenator blood loss occurred during oxygenator change out. Prolonged procedure caused increased assistance in post declamping if any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
 
Event Description
Sorin group (b)(4) has received a report of oxygenator low pressure during procedure. Surgery was prolonged of 30 minutes. There is not report of any patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINSPIRE 8 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 Key12802621
MDR Text Key283483343
Report Number9680841-2021-00031
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeTS
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 01/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03703
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-