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 Consequences Or Impact To Patient (2199)

Event Date 12/14/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided. The inspire 8f hollow fiber 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 hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa. The stand-alone 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 hollow fiber oxygenator. The incident occurred in (b)(4); united states. The involved device has been requested for return to sorin group (b)(4) for investigation and it has not yet been 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)(6) has received a report that, during a procedure, red tinged water was noticed in the heater cooler lines of the inspire 8f oxygenator. The medical team elected to complete the procedure. There is not report of any patient injury.

• 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, modena
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 9568215
• MDR Text Key: 219775637
• Report Number: 9680841-2020-00002
• 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: 04/23/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 03705
• Device Lot Number: 1909060035
• 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: 04/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial