MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND 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 01/02/2015

Event Type  Other  

Event Description

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

Manufacturer Narrative

There was no pt involvement.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 (b)(4) received a report that the touch screen of the sorin centrifugal pump was unresponsive during set up.There was no pt involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

The sorin group (b)(4) manufactures the sorin centrifugal pump 5 (cp5).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the touch screen of the centrifugal pump was unresponsive during set up.As a result of the investigation, a problem with the touch screen was found.Liquid penetrated into the touch screen, causing the reported issue.The touch screen was replaced.Manufacturing records showed no nonconformities.No trend has been identified.No further action is deemed necessary.Sorin group (b)(4) will continue to monitor the market for trends related to the issue.

• Brand Name: SORIN CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CARDIOPULMONARY BYPASS PUMP SPEED CONTROL
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; 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, qa ; 14401 w. 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4747730
• MDR Text Key: 5706481
• Report Number: 9611109-2015-00141
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• 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
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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