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

Catalog Number 044014200

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2015

Event Type  No Answer Provided  

Manufacturer Narrative

There was no patient involvement.The inspire 6f hollow fiber oxygenator was assembled into a customized circuit that is distributed in the usa.The 510k number of the sterile oxygenator that is distributed in the usa is k130433.Sorin group (b)(4) manufactures the inspire 6f hollow fiber oxygenator.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group received a user medwatch report on december 28th, 2015, stating that while setting up the bypass, the perfusionist inadvertently swopped the oxygenator inlet and outlet tubing.The oxygenator was assembled into a customized pack sold in the usa.There was no patient involvement.The investigation is on going.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a user medwatch report on december 28th, 2015, stating that while setting up the bypass, the perfusionist inadvertently swopped the oxygenator inlet and outlet tubing.The oxygenator was assembled into a customized pack sold in the usa.There was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the inspire 6f hollow fiber oxygenator.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group received a user medwatch report on december 28th, 2015, stating that while setting up the bypass, the perfusionist inadvertently swopped the oxygenator inlet and outlet tubing.The oxygenator was assembled into a customized pack sold in the usa.There was no patient involvement.A review of the technical documentation of the convenience pack which the complained device was assembled into found that the connection of the arterial and venous line to the oxygenator outlets were not preassembled.The arterial and venous outlets are indicated with red and blue caps, respectively, and the instructions for use (ifu) clearly designates how to correctly assemble the lines according to the rotation of the main pump.Sorin group (b)(4) has determined that this issue was the result of the user failing to adhere to the assembly instructions outlined in the ifu.Although this is the unique case, sorin group usa, where the convenience pack is assembled, has modified the technical documentation of the convenience pack into which the complained oxygenator was included to introduce pre-connection of the lines to the appropriate oxygenator ports.This will prevent future occurrences of inverting the oxygenator inlet and outlet tubing.

• Brand Name: INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR W INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (modena), italy 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo), 41037 ; IT 41037
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5386592
• MDR Text Key: 36707296
• Report Number: 9680841-2015-00669
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Catalogue Number: 044014200
• Device Lot Number: 1523600058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1