MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 CONTROL PANEL MRP 150/85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	28-95-80
Medical Device Problem Codes	Failure to Pump (1502); Pumping Stopped (1503)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Sorin group (b)(4) manufactures the s5 control panel mast roller pump 150.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 pump stop message appeared on the s5 control panel mast roller pump during in-service when using pump #1, and the pump for stop link could not be accessed when pump #1 was selected.There was no patient involvement.The service representative on-site tested the unit and found that the pump worked when set to a different pump number.The mast roller pump control panel was replaced.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
Event or Problem Description
Sorin group (b)(4) received a report that a pump stop message appeared on the s5 control panel mast roller pump during in-service when using pump #1, and the pump for stop link could not be accessed when pump #1 was selected.There was no patient involvement.

• Brand Name: S5 CONTROL PANEL MRP 150/85
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• MDR Report Key: 5807457
• Report Number: 9611109-2016-00435
• Device Sequence Number: 10871550
• Product Code: DWB
• UDI-Device Identifier: 04033817900818
• UDI-Public: 010403381790081811160412
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2016

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
• Operator of Device: Health Professional
• Device Model Number: 28-95-80
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2016
• Initial Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1