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

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.

• Brand Name: INSPIRE 8F HOLLOW FIBER OXYGENATOR
• 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: 12867866
• MDR Text Key: 283255109
• Report Number: 9680841-2021-00033
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 03705
• Device Lot Number: 2106250003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial