MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 6F HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES OXYGENATOR, CARDIOPULMONARY BYPASS,

Catalog Number IN00657

Device Problem Fluid Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

This report was originally submitted on november 16, 2016 as 9680841-2016-00514. However, a review of previously filed reports identified that an error occurred during the submission process, and the submission failed. This report is being resubmitted under a different report number. The complained inspire 6f hollow fiber oxygenator was a non-sterile component assembled into a sterile convenience pack that is not distributed in the usa. The catalog number, lot number, and expiration date refer to the sterile finished product into which the oxygenator was assembled. As the sterile finished product is not distributed in usa, there is no unique identifier (udi) number. However, the complained device is similar to the inspire 6f oxygenator catalog number 050702, which is distributed in the usa, for which the device identifier is (b)(4). The inspire 6f hollow fiber oxygenator was a non-sterile component assembled into a convenience pack that is not distributed in the usa. The stand alone oxygenator (catalog number 050702) is registered in the usa (510(k) number: k120185). 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 6f hollow fiber oxygenator module. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). On october 19, 2016, sorin group (b)(4) was notified that the user facility had submitted a report to the local competent authority. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The device has not yet been returned to sorin group (b)(4) for investigation. A follow-up report will be sent when the investigation will be completed.

Event Description

Sorin group (b)(4) received a report that a blood leak was detected by the luer-lock on the arterial sampling line of the inspire 6f oxygenator at the beginning of the procedure. The medical team elected to interrupt the procedure to exchange the circuit. Blood was transfused to the patient. The facility has not disclosed the patient status.

Manufacturer Narrative

(b)(4). Sorin group (b)(4) manufactures the inspire 6f hollow fiber oxygenator module. The incident occurred in (b)(6). (b)(4). The device was returned to sorin group (b)(4) for investigation. Visual inspection of the returned oxygenator found dried residual blood between the oxygenator blood outlet connector and the assembled tubing. An additional tie band was identified close where the dried blood was visible. The additional tie is not in the technical drawing of the circuit and was placed on top of the tie band that was placed by sorin group during assembly. No abnormalities, cracks or other defects were identified during the inspection. During leak testing, the oxygenator was filled with solution and pressurized to values above those recommended in the product instructions for use (ifu). During the test, no leak from any part or connection of the oxygenator was identified. The tubing connected to the oxygenator blood outlet connector was disassembled and subjected to dimensional analysis and was found to be within specification. Though the reported leak was not reproduced or confirmed through leak testing and dimensional analysis, the issue was confirmed based on the presence of residual dried blood in the connection between the blood out connector and the tubing. The exact root cause was not determined. However, a potential cause for the leak is tube deformation that could have occurred during manual assembly. The relevant manufacturing floor personnel have been made aware of the event.

• Brand Name: INSPIRE 6F HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS,
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; miradola (modena)
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (modena) 41037 ; IT 41037
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6209081
• MDR Text Key: 63410365
• Report Number: 9680841-2016-00522
• 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

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2019
• Device Catalogue Number: IN00657
• Device Lot Number: 1606290055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 10/20/2016
• Device Age: 5 MO
• Event Location: No Information
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial