MAUDE Adverse Event Report: SORIN GROUP ITALIA APEX HP M P.H.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050554

Device Problem Air Leak (1008)

Patient Problem Death (1802)

Event Date 02/04/2016

Event Type  Death  

Manufacturer Narrative

Sorin group (b)(4) manufactures the apex hp m p.H.I.S.I.O.Adult hollow fiber membrane oxygenator.The incident occurred.Sorin group (b)(4) received a report that there was air in the arterial line that was delivered to the patient during a procedure involving the apex hp m p.H.I.S.I.O.Adult hollow fiber membrane oxygenator.The facility is still in the process of determining if the air was introduced before or after the oxygenator.The patient died as a result of the injury.A review of the device history record was unable to identify any deviations or non-conformities relevant to the issue.The involved device has been requested for return.A follow up report will be sent when the investigation is completed.Device not yet received from customer.

Event Description

Sorin group (b)(4)received a report that there was air in the arterial line that was delivered to the patient during a procedure involving the apex hp m p.H.I.S.I.O.Adult hollow fiber membrane oxygenator.The facility is still in the process of determining if the air was introduced before or after the oxygenator.The patient died as a result of the injury.

Manufacturer Narrative

A review of the initial report, which was filed on march 7, 2016, found that the first sentence of the manufacturer narrative was truncated.The full narrative should have read: sorin group (b)(4) manufactures the apex hp m p.H.I.S.I.O.Adult hollow fiber membrane oxygenator.The incident occurred (b)(6).This report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that there was air in the arterial line that was delivered to the patient during a procedure involving the apex hp m p.H.I.S.I.O.Adult hollow fiber membrane oxygenator.The facility is still in the process of determining if the air was introduced before or after the oxygenator.The patient died as a result of the injury.A review of the device history record was unable to identify any deviations or non-conformities relevant to the issue.The involved device has been requested for return.A follow up report will be sent when the investigation is completed.

Manufacturer Narrative

Pt gender.Male.Date of death: (b)(6) 2016.Report sent to fda.Yes.Sorin group (b)(4) manufactures the apex hp m p.H.I.S.I.O.Adult hollow fiber membrane oxygenator.The incident occurred (b)(6).This report is being filed on behalf of sorin group (b)(4).Sorin group received a report that there was air in the arterial line that was delivered to the patient during a procedure involving the apex hp m p.H.I.S.I.O.Adult hollow fiber membrane oxygenator.The facility is still in the process of determining if the air was introduced before or after the oxygenator.The patient died as a result of the injury.On (b)(6) 2016, sorin group received a user medwatch report (mw5060251) related to this case.The user report stated that the air was pumped into the line shortly after initiation of coronary bypass.The lines were disconnected, de-aired and reconnected.The patient was stable for the remainder of the case.The patient expired after being transported to surgical icu following the procedure.The facility is still investigating the event to determine the root cause.The involved oxygenator and reservoir were returned to sorin group usa for evaluation.Visual inspection of the returned devices found no defects or abnormalities with the products.A leak test was performed on the oxygenator and no leaks were identified.Both the reservoir and oxygenator were subjected to simulated use testing at a pressure of 250mmhg and a flow rate of 1lpm and no leaks were identified.The device has been shipped to sorin group (b)(4) for further investigation.A follow-up report will be submitted when the investigation is complete.Evaluated by sorin group usa.

Manufacturer Narrative

Sorin group (b)(4) manufactures the apex hp m p.H.I.S.I.O.Adult hollow fiber membrane oxygenator.The incident occurred (b)(6).This report is being filed on behalf of sorin group (b)(4).Sorin group received a report that there was air in the arterial line that was delivered to the patient during a procedure involving the apex hp m p.H.I.S.I.O.Adult hollow fiber membrane oxygenator.The facility is still in the process of determining if the air was introduced before or after the oxygenator.The patient died as a result of the injury.On (b)(6) 2016, sorin group received a user medwatch report (mw5060251) related to this case.Investigation of the device at sorin group usa was unable to reproduce the reported issue.The device was shipped to sorin group (b)(4) for further investigation.The returned device was visually inspected and functionally tested.Visual inspection identified two level sensors that are neither manufactured nor sold by sorin group.One of the sensors was found to be severely damaged.The oxygenator was pressurized and submerged in water and no leaks were observed.The unit underwent a priming test and was able to be de-bubbled without any difficulty.Bovine blood was circulated through the unit at both the minimum and maximum recommended blood flows and no evidence of bubble activity was observed.The issue could not be reproduced.A review of the device history record was unable to identify any deviations or non-conformities relevant to the reported issue.As the issue could not be reproduced, a root cause was not identified and corrective actions were not determined.No defects were identified with the returned device.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.

• Brand Name: APEX HP M P.H.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord 86; mirandola (mo), 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola, 41037 ; IT 41037
• Manufacturer Contact: carrie wood ; 14401 w 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5484802
• MDR Text Key: 39839790
• Report Number: 9680841-2016-00102
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2016
• Device Catalogue Number: 050554
• Device Lot Number: 1508310002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 03/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/10/2016; 04/15/2016; 07/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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 Outcome(s): Death
• Patient Age: 81 YR
• Patient Weight: 85