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

Device Problems Low Readings (2460); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  malfunction  

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 (b)(4) , 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 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.

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).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
• Type of Device: 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)
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6402817
• MDR Text Key: 69951218
• Report Number: 9680841-2017-00007
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178100359
• UDI-Public: (01)08033178100359(17)190315(10)1603140132
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Physician
• Device Expiration Date: 03/15/2019
• Device Catalogue Number: 050531
• Device Lot Number: 1603140132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/13/2017
• Device Age: 11 MO
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 8 MO
• Patient Weight: 5