MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050713

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided. Sorin group (b)(4) manufactures the inspire 6 hollow fiber oxygenator with integrated and hardshell. The incident occurred in (b)(6). The involved device has not been requested for return to sorin group (b)(4) for investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) has received a report that, 15 minutes after initiation of a procedure, high delta membrane pressure was observed. The medical team elected to change out the oxygenator. There is not report of any patient injury.

• Brand Name: INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR
• Type of Device: OXYGENATOR, 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 Key: 12664702
• MDR Text Key: 277399060
• Report Number: 9680841-2021-00030
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K130209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 050713
• Device Lot Number: 2009210001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial