MAUDE Adverse Event Report: SORIN GROUP USA, INC. SORIN CENTRIFUGAL PUMP 5(CP5); CARGIOPULMONARY BYPASS PUMP SPEED CONTROL

Model Number 600-00-60

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

Patient Problem No Patient involvement (2648)

Event Date 10/23/2014

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report that the sorin centrifugal pump touch screen was unresponsive during set up.There was no pt 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).The investigation is ongoing.A f/u report will be sent when the investigation is complete.

Manufacturer Narrative

The reported issue could be reproduced residue was found on an edge of the screen.A new screen was fitted and the cp5 was tested with no issues found.No nonconformities were noted during manufacturing record review.No trend has been identified, no further investigation is required.The issue will be monitored for trends and if identified, corrections will be recommended.

• Brand Name: SORIN CENTRIFUGAL PUMP 5(CP5)
• Type of Device: CARGIOPULMONARY BYPASS PUMP SPEED CONTROL
• Manufacturer (Section D): SORIN GROUP USA, INC.; lindberghstr. 25; munich D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich D 809 39; GM D 80939
• Manufacturer Contact: cheri voorhees, mgr ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4279846
• MDR Text Key: 5294582
• Report Number: 1718850-2014-00442
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Unknown
• Type of Report: Initial,Followup
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 600-00-60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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