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 Patient involvement (2648)

Event Date 03/08/2014

Event Type  Other  

Event Description

Sorin group (b)(4) rec'd a report that the display of the stockert centrifugal pump showed only dashes during set up.There was no pt involvement.

Manufacturer Narrative

There was no pt involvement.Sorin group (b)(4) manufactures the stockert centrifugal pump with tubing clamp.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) rec'd a report that the display of the stockert centrifugal pump showed only dashes during set up.There was no pt involvement.The investigation is ongoing.A f/u 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 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, mgr ; 14401 w. 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3800533
• MDR Text Key: 4521820
• Report Number: 1718850-2014-00122
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• 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: 04/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2007
• 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