MAUDE Adverse Event Report: SORIN GROUP ITALI SRL INSPIRE 8F HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VEN/CARDIOTOMY RESERV; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number IN00262

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2016

Event Type  malfunction  

Manufacturer Narrative

The complained inspire 8f hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir 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 inspire 8f is similar to the inspire 8f oxygenator 050716, which is distributed in the usa, for which the device identifier is (b)(4).(b)(6).The inspire 8f hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir was a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone oxygenator is registered in the usa (510(k) number: k130433).Sorin group (b)(4) manufactures inspire 8f 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).Sorin group (b)(4) received a report that a blood leak from the bottom of the inspire 8f oxygenator was observed 60 minutes into bypass.The medical team elected to use the device to complete the procedure.The was no report of patient injury.On september 23, 2016, sorin group (b)(4) was notified that the user facility had submitted a report to the local competent authority.This medwatch report is being filed in response to this action.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The device was returned to sorin group (b)(4) for investigation and has been sent for decontamination.The investigation is on-going.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 from the bottom of the inspire 8f oxygenator was observed 60 minutes into bypass.The medical team elected to use the device to complete the procedure.The was no report of patient injury.On september 23, 2016, sorin group (b)(4) was notified that the user facility had submitted a report to the local competent authority.This medwatch report is being filed in response to this action.

Manufacturer Narrative

Sorin group (b)(4) manufactures inspire 8f hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir.The incident occurred in (b)(6).The oxygenator was returned to sorin group (b)(4) for further investigation.The device was leak tested with a blue dye solution, which confirmed the presence of a damaged fiber that resulted in a leak in the gas compartment of the oxygenator.The damaged fiber was located in the central part of oxygenator fiber bundle.Based on the review of the dhr, the complained oxygenator successfully passed the in-process leak test.Sorin group (b)(4) identified the most probable cause of the leak to be a damaged fiber that passed the in process leak test but was further damaged through thermal and mechanical stress during sterilization, transport and use.Human error during the in-process leak testing cannot be excluded as another possibility.Despite the low frequency and risk level for this type of event, an automated vision system for in-process control of the inspire oxygenator fiber integrity is being introduced to eliminate potential human error.

• Brand Name: INSPIRE 8F HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VEN/CARDIOTOMY RESERV
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALI 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 cesar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6043423
• MDR Text Key: 58019759
• Report Number: 9680841-2016-00508
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: IN00262
• Device Lot Number: 1602120073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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