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

Model Number 60-02-50

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

Patient Problem No Patient involvement (2648)

Event Date 11/17/2014

Event Type  Other  

Event Description

Sorin group (b)(4) a report that the flow on the scp display changed to dashes during set up.There was no pt involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the centrifugal pump with tubing clamp.The incident occured in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is ongoing.A follow-up will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group (b)(4) manufactures the centrifugal pump.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 flow rate on the scp display changed to dashes during set up.The facility retained the questionable unit.No investigation could be performed.The sorin group representative did replace the scp control panel and all testing showed no issues.There has been no report of re-occurrence received.No nonconformities were noted during the device history record review related to this issue.The issue will be monitored for trends and if identified, corrections will be recommended.

• Brand Name: STOCKERT CENTRIFUGAL PUMP WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindberghst 25 ; munich D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND ; lindberghst 25 ; munich D 809 39; GM D 80939
• Manufacturer Contact: cherry voorhess, mgr ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4356803
• MDR Text Key: 20454829
• Report Number: 1718850-2014-00475
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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