MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 CONTROL PANEL MRP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 28-95-80

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.(b)(4) manufactures the s5 control panel mrp.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 first tried replacing the motor control board in the pump head, but the issues recurred so the pump and controller were removed from service for further investigation.The issue was recreated and an error message appeared stating "shaft encoder fault." the shaft encoder was visually inspected and a damaged wire was identified.The damaged component was replaced to resolve the issue.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the s5 control panel mast roller pump (mrp) displayed an error message on the central panel and the pump stopped during a procedure.The user utilized the hand crank to continue the case.There was no report of patient injury.

Manufacturer Narrative

The device was not returned for investigation.A review of the dhr could not be performed.Capa (b)(4) has been initiated.The root cause was determined; the wiring was partially cut because the fan was too close to the shaft angle encoder.The new design of the control panel moved the location of the wiring to prevent the wiring from being cut.It was concluded that the way the harness cables were initially routed may have contributed to the damage, which created the pump stop.

• Brand Name: S5 CONTROL PANEL MRP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich,
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich,
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6326100
• MDR Text Key: 67335730
• Report Number: 9611109-2017-00068
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28-95-80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2007
• 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