MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 ELECTRONIC GAS BLENDER SYSTEM; 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 Patient involvement (2648)

Event Date 09/09/2014

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report that the electronic gas blender displayed an error during set up.There was no pt involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the electronic gas blender system.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 electronic gas blender system.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the electronic gas blender displayed an error during set up.The reported issue was reproduced.An error in the calibration was identified.The unit was re-calibrated and tested with no further issues.No nonconformities were noted during delivery history record review.The issue will be monitored for trends and if identified, corrections will be recommended.

• Brand Name: S5 ELECTRONIC GAS BLENDER SYSTEM
• 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; mubich D 809 39; GM D 80939
• Manufacturer Contact: cheri voorhees, mgr, quality as ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4208996
• MDR Text Key: 5043249
• Report Number: 1718850-2014-00396
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2014

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 10/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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