MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH SORIN CENTRIFUGAL PUMP 5 (CP5); CARDIOPULMONARY BYPASS PUMP SPEED CONTROL

Model Number 60-02-60

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

Patient Problem No Patient involvement (2648)

Event Date 01/26/2015

Event Type  Other  

Event Description

Sorin received a report that the touch screen of the sorin centrifugal pump was unresponsive during set up.There was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin centrifugal pump 5 (cp5).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 touch screen of the sorin centrifugal pump was unresponsive during set up.There was no patient involvement.The investigation is ongoing.A follow up report will be sent when the investigation is complete.

Manufacturer Narrative

The service representative noted a crack on the touch screen.The touch screen was replaced, the unit tested and returned to service.The touch screen was returned to sorin for evaluation.Visual inspection determined that the touch screen showed signs of fluid damage.No further investigation is required.No trend increase has been identified.No nonconformities were noted during the device history record review regarding this issue.The issue will be monitored for trends and if identified, corrections will be recommended.

• Brand Name: SORIN CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CARDIOPULMONARY BYPASS PUMP SPEED CONTROL
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; lindbergh strasse 25; munchen 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND ; lindbergh strasse 25; munchen 80939 ; GM 80939
• Manufacturer Contact: cheri voorhees, mgr. ; 14401 w. 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4609658
• MDR Text Key: 5658714
• Report Number: 9611109-2015-00063
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2015

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: 60-02-60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 03/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2004
• 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