MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	6F DUAL PH.I.S.I.O.
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.The age of the device was calculated as the time elapsed between device sterilization and the date of event.(b)(4).Sorin group (b)(4) manufactures the inspire 6f dual hollow fiber oxygenator with integrated arterial filter.The incident occurred in (b)(6).Per exemption number e2016005.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.The complete pump sheet was also requested, but has not been made available at this time.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device requested, not yet returned.
Event or Problem Description
Sorin group (b)(4) received a report that the venous saturation of the inspire 6f dual hollow fiber oxygenator dropped to 42% for around 6 minutes and the oxygenation decreased after starting ventilation during a coronary artery bypass graft surgery.The oxygenator was changed out without any interruption of the procedure thanks to a shunt.Full flow was pushed up to 7 l/min to accommodate the flow to 2 l/min in the new oxygenator.There was no report of patient injury.
Additional Manufacturer Narrative
(b)(4) manufactures the inspire 6f dual hollow fiber oxygenator with integrated arterial filter.The incident occurred in (b)(6).Per exemption number e2016005, (b)(4) is submitting the report for both (b)(4) (manufacturer) and livanovausa., inc.(importer).The affected device, initially reported to be available for return, has not been returned to manufacturer.No additional information on the case were provided despite the repeated attempt.As no device investigation was possible, no root cause can be assessed.

• Brand Name: INSPIRE 6 DUAL 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, modena 41037 ; IT 41037
• MDR Report Key: 7163234
• Report Number: 9680841-2018-00001
• Device Sequence Number: 16638972
• Product Code: DTZ
• UDI-Device Identifier: 08033178112413
• UDI-Public: (01)08033178112413(17)200617(10)1706190012
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K121909
• 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): 03/27/2018

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: 06/17/2020
• Device Model Number: 6F DUAL PH.I.S.I.O.
• Device Catalogue Number: 050719
• Device Lot Number: 1706190012
• Was Device Available for Evaluation?: Yes
• Device Age: 6 MO
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1