MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8F DUAL HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES.; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	050716
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2016
Additional Manufacturer Narrative
(b)(6).The telephone number is being included in the manufacturer narrative, as the formatting required is not compatible with as2 feed.Sorin group (b)(4) manufactures the inspire 8f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir.The incident occurred in genova, italy.This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that, during extracorporeal circulation, a blood leak was detected from the temperature probe of the inspire 8f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir.There was no report of patient injury.Sorin group (b)(4) has been made aware that the user facility 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 investigation is on-going.A follow-up report will be sent when the investigation will be completed.
Event or Problem Description
Sorin group (b)(4) received a report that, during extracorporeal circulation, a blood leak was detected from the temperature probe of the inspire 8f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir.There was no report of patient injury.
Additional Manufacturer Narrative
Sorin group (b)(4) manufactures the inspire 8f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that, during extracorporeal circulation, a blood leak was detected from the temperature probe of the inspire 8f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir.There was no report of patient injury.Sorin group (b)(4) has been made aware that the user facility submitted a report to the local competent authority.This medwatch report is being filed in response to this action.The complained oxygenator was returned to sorin group (b)(4) and subjected to visual inspection and air leak testing.Initial visual inspection did not identify any residual blood in the area where the customer described that the leak occurred.During leak testing, the device was pressurized with air at 1 bar for 15 min and no leak could be reproduced; the device behaved as expected.The returned device was found to be conforming to specification.Sorin group (b)(4) cannot exclude the possibility that the reported leak occurred elsewhere in the system and dripped onto the oxygenator at the reported location.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.No malfunction was identified and no further action has been deemed necessary.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.

• Brand Name: INSPIRE 8F DUAL HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES.
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola, mirandola (modena)
• MDR Report Key: 5850213
• Report Number: 9680841-2016-00495
• Device Sequence Number: 13663498
• Product Code: DTZ
• UDI-Device Identifier: 08033178112383
• UDI-Public: (01)08033178112383(17)190524(1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2019
• Device Catalogue Number: 050716
• Device Lot Number: 1605230095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2016
• Supplement Report FDA Received Date: 10/20/2016
• Patient Sequence Number: 1
• Patient Age: 79 YR