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

Model Number 60-03-00

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Device has not been returned to sorin group (b)(4).Sorin group manufactures the sorin centrifugal pump console (scpc).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 console became unresponsive during a procedure.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate the reported issue.The service representative found that fluid penetration into the touch screen was the cause of the reported issue.The touch screen was replaced and photos of the replaced device were sent to sorin group (b)(4) for evaluation.Through photographic inspection, sorin group was able to confirm the reported issue and identified the root cause to be fluid penetration into the touch screen.A review of the dhr did not identify any deviations or non-conformities relevant to the reported failure.Sorin group (b)(4) has initiated a capa in response to this type of issue.

Event Description

Sorin group (b)(4) received a report that the touch screen of the sorin centrifugal pump console became unresponsive during a procedure.There was no report of patient injury.

• Brand Name: SORIN CENTRIFUGAL PUMP CONSOLE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr.25; munich, 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5511427
• MDR Text Key: 40730415
• Report Number: 9611109-2016-00127
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K020571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/22/2016

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: 60-03-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2004
• 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