MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 6F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER & HARDSHELL RES; HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER & HARDSHELL VENOUS/CARDIOTOMY RES

Model Number	6F M
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).Sorin group (b)(4)manufactures the inspire 6f hollow fiber oxygenator.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).(importer).The involved device was returned to sorin group (b)(4) for investigation.Visual inspection of the unit confirmed that the connector of cardioplegia port was completely detached from the body of the oxygenator.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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)(4) received a report that the cardioplegia connector was discovered to be detached from the body of the inspire 6f hollow fiber oxygenator during set up.There was no patient involvement.
Additional Manufacturer Narrative
Sorin group italia manufactures the inspire 6f hollow fiber oxygenator.The incident occurred in nieuwegein, netherlands.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).Investigation of the returned product confirmed that the valve sub-assembly was not properly bonded to its seat on the oxygenator body.Sorin group italia determined that the most likely root caused was due to a malfunction of the gluing dispenser.To avoid recurrence, dosing parameters and positioning of components to be glued in the gluing dispenser were optimized and an additional visual inspection was implemented.A review of the dhr revealed that the unit successfully passed the in-process leak test, and a complaint history review for this type of issue found that it has only occurred on two units over the past three years.
Event or Problem Description
Sorin group italia received a report that the cardioplegia connector was discovered to be detached from the body of the inspire 6f hollow fiber oxygenator during set up.There was no patient involvement.

• Brand Name: INSPIRE 6F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER & HARDSHELL RES
• Common Device Name: HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER & HARDSHELL VENOUS/CARDIOTOMY RES
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 7468155
• Report Number: 9680841-2018-00011
• Device Sequence Number: 16175002
• Product Code: DTZ
• UDI-Device Identifier: 08033178112277
• UDI-Public: (01)08033178112277(17)201120(10)1711220233
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K130209
• 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): 07/10/2018

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: 11/20/2020
• Device Model Number: 6F M
• Device Catalogue Number: 050702
• Device Lot Number: 1711220233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/29/2018
• Device Age: 4 MO
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1