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

Catalog Number 03707

Device Problem Fluid Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided. The inspire 8 hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack that is not distributed in the usa. The lot of the oxygenator was used by three batches: pr1600028549, pr1600028766 and pr1600028994. As the lot of the sterile finished convenience pack into which the oxygenator was assembled is unknown, the expiration date of the product is unknown. As the sterile is not distributed in usa, the udi number is not applicable. The complained inspire 8 hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa. The stand-alone oxygenator (catalog number 050701) is registered in the usa (510(k) number: k180448). The lot of the oxygenator was used by three batches: pr1600028549, pr1600028766 and pr1600028994. As the lot of the sterile finished convenience pack into which the oxygenator was assembled is unknown, the expiration date of the product is unknown, the device manufacture date is unknown. Sorin group (b)(4) manufactures the inspire 8 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 was disposed, and it is not available for investigation. If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report. Device not available.

Event Description

Sorin group (b)(4) has received a report that, during a procedure, a leak was identified from a crack by the inspire 8 oxygenator. The medical team elected to administer antibiotic to the patient. There is not report of any patient injury.

• Brand Name: INSPIRE 8M HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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: 9563680
• MDR Text Key: 196290314
• Report Number: 9680841-2020-00001
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/02/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 03707
• Device Lot Number: 1907180004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial