MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS CARDIOTOTOMY RESERV; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 8 PH.I.S.I.O.

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2017

Event Type  malfunction  

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 the event.(b)(4).(b)(4) manufactures the inspire 8 hollow fiber oxygenator with integrated hardshell reservoir.The incident occurred in (b)(6).(b)(4).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.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) received a report that low oxygen levels were found by the perfusionist for the inspire 8 hollow fiber oxygenator then the blood gas parameter was analyzed upon the start of bypass.The perfusionist decided to switch to a new membrane oxygenator to continue.The change out was done after cooling down of the patient.Oxygen levels were restored after the change out.There was no report of patient injury.

Manufacturer Narrative

Sorin (b)(4) manufactures the inspire 8 hollow fiber oxygenator with integrated hardshell reservoir.The incident occurred in (b)(6).Per exemption number e2016005, (b)(4).The involved device was returned to sorin group italia for investigation.During visual inspection, no visible defects were noted.A gas exchange performance test was conducted per iso 7199 standard blood conditions.No device malfunction was identified during this testing.The involved device was found to be conforming to the manufacturer specifications.As the issue could not be reproduced, a root cause was not determined.However, the root cause is likely associated with the clinical practice.

• Brand Name: INSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS CARDIOTOTOMY RESERV
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: joan caesar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6787410
• MDR Text Key: 83122330
• Report Number: 9680841-2017-00022
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178112369
• UDI-Public: (01)08033178112369(17)200205(10)1702060154
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2020
• Device Model Number: 8 PH.I.S.I.O.
• Device Catalogue Number: 050714
• Device Lot Number: 1702060154
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/14/2017
• Device Age: 5 MO
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2017
• 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