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

Model Number 10-85-00

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Patient involvement (2648)

Event Date 11/14/2014

Event Type  Other  

Event Description

Sorin group (b)(4) received a report that the touch screen of the s5 double head pump was unresponsive during set up.There was no patient involvement.

Manufacturer Narrative

There was no patient involvement.Sorin group (b)(4) manufactures the s5 double head pump.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 the touch screen of the s5 double head pump was unresponsive during set up.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

(b)(4) manufactures the s5 double head pump.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 the touch screen on the cardioplegia pump was unresponsive during set up.All information was still displayed on the screen.The pump was cycled with no affect.The touch screen was replaced by the service representative.No further issues were found.Photographs received at sorin group (b)(4) indicated that liquid had penetrated into the touch screen, causing the problem.A capa has been generated and is on-going to investigate this problem.A change order was implanted as a corrective action.No nonconformities were noted during device history record review.

• 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; lindbeghstr. 25; munich 80004 ; GM 80004
• Manufacturer Contact: cheri voorhees, manager ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4387934
• MDR Text Key: 15122030
• Report Number: 1718850-2014-00489
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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