MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	03705
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.The inspire 8f hollow fiber oxygenator with integrated arterial filter is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.(b)(4).The age of the device was calculated as the time elapsed between device sterilization and the date of event.Importer (b)(4), manufacturer (sorin group(b)(4)).The involved inspire 8f hollow fiber oxygenator with integrated arterial filter is a non-sterile component assembled into a convenience pack that is distributed in the usa.The stand alone oxygenator (catalog number 050703) is also registered in the usa (510(k) number: k130433).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 8f hollow fiber oxygenator with integrated arterial filter.The incident occurred in(b)(6).Per exemption number e2016005, sorin group (b)(4).Is submitting the report for both sorin group (b)(4) (manufacturer) and (b)(4).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been requested for return to sorin group(b)(4) for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Sorin group (b)(6) received a report that priming fluid was observed leaking from the blood side to the water side of the inspire 8f hollow fiber oxygenator during priming.The customer reported that the fluid passed through with no resistance.There was no patient involvement.
Additional Manufacturer Narrative
After further review, this report was determined to be a duplicate of report number 9680841-2017-00028.As the report is a duplicate, it is void and no further follow-ups will be submitted.For additional details about the event, please refer to 9680841-2017-00028.

• Brand Name: INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• MDR Report Key: 6964226
• Report Number: 9680841-2017-00027
• Device Sequence Number: 13784332
• Product Code: DTZ
• UDI-Device Identifier: 00803622131202
• UDI-Public: (01)00803622131202(240)044002301(17)190731(10)1719900072
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: 07/31/2019
• Device Catalogue Number: 03705
• Device Lot Number: 1705110224
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 09/21/2017
• Device Age: 3 MO
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1