MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050710

Device Problems Disconnection (1171); Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The complained inspire 8 start oxygenator (catalog number 050710, lot 1511020143) is not distributed in the usa, therefore the udi is not applicable. The oxygenator item 050710 is similar to the inspire 8 oxygenator 050714, which is distributed in the usa, for which the device identifier is (b)(4). The product item 050710 is not distributed in the usa, but it is similar to the inspire 8 oxygenator 050714, which is distributed in the usa (510(k) number: k130433). Sorin group (b)(4) manufactures the inspire 8 start hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. Investigation is on-going. A follow-up report will be sent when the investigation is complete. Device not available for return.

Event Description

Sorin group (b)(4) received a report that the transmembrane pressure of the inspire 8 start hollow fiber oxygenator increased and the tubing disconnected from the arterial outlet of the oxygenator. The connection was replaced and the procedure was been continued at a lower blood flow rate. Near the end of the procedure, the user observed the po2 pressure to be very low (90-100mmhg), despite 100% fio2. According to the medical team, the blood loss was 200-400cc and blood had to be transfused to the patient. The conditions of the patient have been reported to be stable.

Manufacturer Narrative

(b)(4) manufactures the inspire 8 start hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir. The incident occurred in (b)(6). The involved oxygenator and the circuit into which the oxygenator was assembled were not made available for investigation at sorin group (b)(4). Therefore, a physical investigation of the unit could not be performed. The pump sheet for the case was provided. However, blood flow data was not included in the sheet. Without the ability to perform a physical investigation of the complained device, an exact root cause could not be determined and corrective actions were not identified. However, investigation of similar events and ongoing review of available medical literature suggests the most probable root cause of platelet adhesion and coagulation is multi-factorial and potentially is influenced by the clinical procedure (e. G surgical material), therapies used (e. G. Anticoagulant prescription, heparin composition and priming composition) and patient-specific health conditions. The oxygenator was manufactured, tested and released in compliance with standard manufacturing procedures. Sorin group (b)(4) will continue to monitor for trends related to this type of issue. Device not available.

• Brand Name: INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (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: 6186184
• MDR Text Key: 62849728
• Report Number: 9680841-2016-00520
• 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: 11/20/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/02/2018
• Device Catalogue Number: 050710
• Device Lot Number: 1511020143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial