MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-15

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2015

Event Type  Other  

Manufacturer Narrative

Pt info was not provided.Sorin group (b)(4) manufacturers the centrifugal pump system.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that flow errors were occurring on the pump system during the procedure.The flow sensor was switched out but the errors were still displayed.The unit was switched out.There was no report of pt injury.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that flow errors were occurring on the pump system during the procedure.The flow sensor was switched out but the errors were still displayed.The unit was switched out.There was no report of pt injury.

Manufacturer Narrative

The device manufacture date provided in the initial report was incorrect.The correct device manufacture date is february 9, 2005.(b)(4) manufactures the scp centrifugal pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).A sorin group field service representative was dispatched to the facility to investigate.The service representative was able to reproduce the reported issue and identified the root cause to be a faulty flow board.The issue was resolved by replacing the flow board.Sorin group (b)(4) has not been made aware of any further issues following the replacement.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.Evaluated on site by sorin service rep.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghst 25; munich D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5075005
• MDR Text Key: 25999116
• Report Number: 9611109-2015-00368
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2005
• 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