MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050712

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Pma 510(k).The inspire 8f m hollow fiber oxygenator was assembled into a customized circuit that is not distributed in the usa, but it is similar to the sterile oxygenator that is distributed in the usa (510k#: k130433).At the date of the present report, the unit has not been returned to the manufacturer facilities for investigation.Sorin group (b)(4) manufactures the inspire 8 start p hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group received a report that the inspire 8 start p hollow fiber oxygenator poorly oxygenated during a procedure.The patient was ventilated and the procedure was completed with no other issue.There was no report of patient injury.The investigation is on going.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the inspire 8 start p hollow fiber oxygenator poorly oxygenated during a procedure.The patient was ventilated and the procedure was completed with no other issue.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the inspire 8 start p hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the inspire 8 start p hollow fiber oxygenator poorly oxigenated during a procedure.The patient was ventilated and the procedure was completed with no other issue.There was no report of patient injury.The device was not returned to sorin group (b)(4) for further investigation, so a physical evaluation was not possible.A review of the device history record was performed and no deviations or non-conformities relevant to the reported issue were discovered.As the device was not returned, the issue could not be confirmed.A root cause was not determined and corrective actions were not identified.Sorin group (b)(4) will monitor the market for trends related to this type of issue.Device not returned by customer.

• Brand Name: INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (modena), italy 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: 5362251
• MDR Text Key: 35733565
• Report Number: 9680841-2015-00667
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2018
• Device Catalogue Number: 050712
• Device Lot Number: 1508210042
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2015
• 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