MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLMAP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-01-00

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

Patient Problem No Patient involvement (2648)

Event Date 01/02/2014

Event Type  Other  

Event Description

Sorin group received a report that there were no flow readings being displayed on the stockert centrifugal pump during set up.There was no pt involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the stockert centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that there were no flow readings being displayed on stockert centrifugal pump during set up.There was no pt involvement.A sorin group filed service rep was dispatched to the facility to investigate.While at the facility, the service representative confirmed the issue and replaced the scp flow board and subsequent testing found the equipment to be functioning properly.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

• Brand Name: STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLMAP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich D809 39; GM D80939
• Manufacturer (Section G): SORING GROUP DEUTSCHLAND; lindberghstr. 25; munich D809 39; GM D80939
• Manufacturer Contact: cheri voorhees, mg ; 14401 w. 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3641630
• MDR Text Key: 4282957
• Report Number: 1718850-2014-00015
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032213
• 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: 01/15/2014

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: 60-01-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2014
• Initial Date FDA Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2006
• 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