MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 DOUBLE HEAD PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-85-00

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The event date has not been reported.This information will provided in a supplemental report if and when made available.Sorin group (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the touch screen of the s5 double head pump intermittently did not work.There was no patient injury.A sorin group field service representative was dispatched to the facility to investigate.The touch screen 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 touch screen of the s5 double head pump intermittently did not work.There was no patient injury.

• Brand Name: S5 DOUBLE HEAD PUMP
• 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; lindbergstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5948095
• MDR Text Key: 54630540
• Report Number: 9611109-2016-00628
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-85-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2005
• 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