MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR; HOLLOW FIBER MEMBRANE OXYGENATOR WITH HARDSHELL CARDIOTOMY/VENOUS RESERVOIR

Catalog Number	050531
Medical Device Problem Codes	Low Readings (2460); Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier was not provided.Initial reporter telephone number: (b)(6).The age of the device was calculated as the time elapsed between the device sterilization and the date of event.(b)(4).Sorin group (b)(4) manufactures the d 100 ph.I.S.I.O.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).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.Device not available for inspection.
Event or Problem Description
Sorin group (b)(4) received a report that the arterial gas (oxygen) levels of the d 100 ph.I.S.I.O.Oxygenator dropped to low values during a procedure.The procedure was completed without changing the oxygenator.There is no report of patient injury.
Additional Manufacturer Narrative
Sorin group (b)(4) manufactures the d 100 ph.I.S.I.O.Hollow fiber oxygenator.The incident occurred in (b)(6).(b)(4).Per exemption number e2016005.The device was not made available for investigation by the customer.However, the blood flow and oxygen flow data recorded by the customer during the procedure were provided, which indicated that the optimal gas/blood flow ratio described in the instructions for use (ifu) was not achieved, while maximum blood flow rate was exceeded.This may be the cause of oxygenator poor gas exchange.Without the ability to investigate the device, a device failure could not be confirmed and a root cause could not be determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• Brand Name: D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR
• Common Device Name: HOLLOW FIBER MEMBRANE OXYGENATOR WITH HARDSHELL CARDIOTOMY/VENOUS RESERVOIR
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (mo)
• MDR Report Key: 6402817
• Report Number: 9680841-2017-00007
• Device Sequence Number: 663227
• Product Code: DTZ
• UDI-Device Identifier: 08033178100359
• UDI-Public: (01)08033178100359(17)190315(10)1603140132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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: Physician
• Device Expiration Date: 03/15/2019
• Device Catalogue Number: 050531
• Device Lot Number: 1603140132
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/13/2017
• Device Age: 11 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2017
• Supplement Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 MO
• Patient Weight: 5