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

Model Number 10-80-00

Device Problems Device Inoperable (1663); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2015

Event Type  malfunction  

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.

Event Description

Sorin group (b)(4) received a report that the roller pump touchscreen 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 being filed on behalf of sorin group (b)(4).Sorin group received a report that the touch screen of the s5 roller pump became unresponsive during set-up.There was no patient involvement.The clinical engineering department for the hospital was dispatched.The touch screen was dismantled and cleaned thoroughly in (b)(6) 2015 to remove suspected spillage.No further problems have been reported.A review of the dhr identified two deviations relevant to the reported failure.Corrective actions were already implemented at that time.A capa for this type of issue has already been implemented as corrective action, and two change orders have been implemented as corrections.Evaluated on site by clinical eng.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindbergh strasse 25; munich D-809 39; GM D-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: 5001248
• MDR Text Key: 24798407
• Report Number: 9611109-2015-00285
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K0171318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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