MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL OXYGENATOR, CARDIOPULMONARY BYPASS INSPIRE 6 PHISIO OXY MODULE WITH INTEGRATED PHISIO HARD SHELL SINGLE CHAMBER RE

Catalog Number 03706

Device Problem Fluid Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2019

Event Type  malfunction  

Manufacturer Narrative

No patient information has been provided. The inspire 6 phisio oxygenator is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa. The lot of the sterile convenience pack is unknown. The expiration date and the unique identifier (udi) are unknown. The involved inspire 6 phisio oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa. The standalone oxygenator (catalog number 050700) is also registered in the usa (510(k) number: k180448). The lot of the sterile convenience pack is unknown. The device manufacture date refers is unknown. Sorin group (b)(4) manufactures the inspire 6 phisio oxygenator. The incident occurred in (b)(6) (united states). The involved device has been requested for return to sorin group (b)(4) for investigation but not yet 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)(4) has received a report that, 30 minutes after the bypass was begun, a leak near the temperature port of the inspire 6 oxygenator was identified. The medical team elected to change out the oxygenator. The change out took 5 minutes. The procedure was completed with no issue. There is not report of any patient injury.

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: INSPIRE 6 PHISIO OXY MODULE WITH INTEGRATED PHISIO HARD SHELL SINGLE CHAMBER RE
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 9437883
• MDR Text Key: 208577018
• Report Number: 9680841-2019-00041
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/09/2019
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 03706
• Device Lot Number: 1906040008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial