MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S3 DOUBLE HEAD PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-65-00

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

Patient Problem No Patient involvement (2648)

Event Date 02/04/2014

Event Type  Other  

Event Description

Sorin group (b)(4) received a report that during set up when pressing the standby button, the s3 double head pump was rotating.There was no pt involvement.

Manufacturer Narrative

There was no pt involvement.Sorin group (b)(4) manufactures the s3 double head pump.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 during set up when pressing the standby button, the s3 double head pump was rotating.There was no pt involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

• Brand Name: S3 DOUBLE HEAD PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich D 80 939; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich D 80 939; GM D 80939
• Manufacturer Contact: cheri voorhees, manager ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3688142
• MDR Text Key: 4299672
• Report Number: 1718850-2014-00047
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K955038
• 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
• Report Date: 02/05/2014

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: 10-65-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2014
• Initial Date FDA Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2001
• 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