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

Model Number 28-95-80

Device Problems Failure to Pump (1502); Pumping Stopped (1503)

Patient Problem No Patient Involvement (2645)

Event Date 06/21/2016

Event Type  malfunction  

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 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
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• 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: 5807457
• MDR Text Key: 49951348
• Report Number: 9611109-2016-00435
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900818
• UDI-Public: 010403381790081811160412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071318
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 28-95-80
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2016
• 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