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 Patient Involvement (2645); No Patient involvement (2648)

Event Date 10/13/2014

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

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).The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

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 stated at turning on the s5 during setup, the touch screen was off, but the user could control the pump with the knob and the leds were in normal operation.Upon checking the internal part of the pump, the service representative found the connector cable loose.The cable has possible compression damage by the structure.A new cable was ordered for the customer.There was no patient involvement.No further investigation is required as no trend increase for this kind of issue was identified.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 the 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: 4259096
• MDR Text Key: 5110805
• Report Number: 1718850-2014-00425
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 10/15/2014
• Initial Date FDA Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2014
• 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