MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 GAS BLENDER; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 25-40-45

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report that the s5 gas blender was not delivering air/o2 to the oxygenator during a procedure.There was no report of patient injury.

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the s5 gas blender.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is ongoing.A follow up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 gas blender.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the s5 gas blender was not delivering air/o2 to the oxygenator during a procedure.There was no report of patient injury.A sorin group service representative was dispatched to the facility to investigate.During initial testing, the service representative was able to reproduce the reported issue.The o2 hose was disconnected and cleaned and appeared to be operating correctly, but the unit still displayed the fault.The gas blender was returned to sorin group deutschland for evaluation.An evaluation of the returned gas blender was performed.During the evaluation, the reported issue was reproduced and the root cause of the failure was found to be a defective bridge (awm 5101 va s3).Additionally, a defective coupling and a defective plug were discovered during the evaluation.A review of the dhr could not identify any concessions, deviations or non-conformities relevant to the reported failure.This issue will be monitored for trends and if a trend is identified, corrective action will be recommended.

• Brand Name: S5 GAS BLENDER
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: cheri voorhees ; 14401 w. 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4036519
• MDR Text Key: 4880665
• Report Number: 1718850-2014-00272
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/22/2014

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: Health Professional
• Device Model Number: 25-40-45
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1