MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH SORIN CENTRIFUGAL PUMP CONSOLE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 60-03-75

Device Problem Pumping Stopped (1503)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/19/2015

Event Type  Other  

Event Description

Sorin group (b)(4) received a report that the scp displayed an error message and the pump stopped during a procedure.The clinician changed out the pump to the backup.The patient required blood products and had severe momentaneous hypotension.

Manufacturer Narrative

The patient identifier was not provided.Sorin group (b)(4) manufacturers the centrifugal pump console.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 spcp displayed an error message and the pump stopped during a procedure.The clinician changed out the pump to the backup.The patient required blood products and had severe momentaneous hypotension.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group (b)(4) manufactures the centrifugal pump console.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 a spcp displayed an error message and the pump stopped during a procedure.The clinician changed out the pump to the backup.As a result of the investigation the service representative found a problem with the backplane board.External devices did not communicate properly with the spcp.The backplane board was replaced and the drive successfully completed all tests performed.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 CONSOLE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; lindbergh strasse 25; munchen D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND GMBH; lindberghstrasse 25; munchen D 809 39; GM D 80939
• Manufacturer Contact: cheri voorhees,mgr ; 14401 w. 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4649686
• MDR Text Key: 5596808
• Report Number: 9611109-2015-00074
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K020571
• 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: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-03-75
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 03/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 100