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

Model Number 10-80-00

Device Problems No Display/Image (1183); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient involvement (2648)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

There was no pt involvement.Sorin group (b)(4) mfrs the s5 roller 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 roller pump was unresponsive during set up.There was no pt involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

The correct serial number is (b)(4).Sorin group (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the touch screen on the cardioplegia pump was non-responsive even though the screen was working visually.There was no patient involvement.Service could not reproduce the reported issue on site.The problem could have been caused by residue from cleaning wipes.All touch screens were cleaned, a new touch screen installed and a nvmem reset performed.The device was returned to service.No nonconformities were noted during device history record review.The issue will be monitored for trends and if identified, corrections will be recommended.

Event Description

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

• Brand Name: S5 ROLLER 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; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: cheri voorhees ; 14401 w. 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4321075
• MDR Text Key: 15316999
• Report Number: 1718850-2014-00446
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/21/2015

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: 10-80-00
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1