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

Model Number 60-02-15

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 03/21/2014

Event Type  Other  

Event Description

Sorin group received a report that the stockert centrifugal pump was not displaying flows and the clinician was unable to initiate delivery of cardioplegia during a procedure.There was no report of patient injury.

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 the stockert centrifugal pump was not displaying flows and the clinician was unable to initiate delivery of cardioplegia during a procedure.There was no report of patient injury.A sorin group field service rep was dispatched to the facility to investigate.While at the facility, the service rep setup a test circuit for the pump.The field service rep was unable to reproduce the reported issue.Additionally an scp test and safety inspections were performed on the device.The investigation is ongoing.A follow up report will be sent when the investigation is complete.

• Brand Name: STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich ; GM
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; arvada CO 80004
• Manufacturer Contact: cheri voorhees, mgr ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3780775
• MDR Text Key: 4442487
• Report Number: 1718850-2014-00113
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2004
• 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