MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 ERC TUBING CLAMP / 620MM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 60-05-65

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 erc (electrical remote controlled) tubing clamp.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 s5 erc tubing clamp of the sorin s5 system overheated during a procedure.The clamp was removed from the s5 and set aside to cool.The customer reported that the device leaked an oily fluid.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to retrieve the complained device and return to sorin group (b)(4) for further investigation.The unit has been received and sorin group (b)(4) and the investigation is in progress.A review of the dhr did not identify any deviations or non-conformities relevant to the reported 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 s5 erc (electrical remote controlled) tubing clamp of the sorin s5 system overheated during a procedure.The clamp was removed from the s5 and set aside to cool.The customer reported that the device leaked an oily fluid.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 erc (electrical remote controlled) tubing clamp.The incident occurred in (b)(6).This medwatch report is filed on behalf of livanova (b)(4).Livanova (b)(4) received a report that the s5 erc tubing clamp of the s5 system overheated during a procedure.The clamp was removed from the s5 and set aside to cool.The customer reported that the device leaked an oily fluid.There was no report of patient injury.A livanova field service representative was dispatched to the facility to retrieve the complained device for further investigation.During investigation, the complaint was confirmed and reproduced.The housing contained fluid, which was identified during visual inspection.Functional testing revealed blood spots and dried saline water on the inside of the panel.It was determined that tssi should conclude if the clamp was repairable or not; other parts needed to be changed.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The root cause was water and blood inside the clamp housing.Corrective actions are currently in progress for this issue.

Event Description

Email from perfusion: it was incredibly hot and you could smell oil.We have removed it from the s5 and kept it to one side cooling but it is leaking oily fluid.

• Brand Name: S5 ERC TUBING CLAMP / 620MM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr.25; munich, 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5835181
• MDR Text Key: 50815151
• Report Number: 9611109-2016-00473
• Device Sequence Number: 1
• Product Code: DTQ
• 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
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-05-65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1