MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S3 OUBLE HEAD PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-65-00

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

Patient Problem No Patient involvement (2648)

Event Date 06/04/2014

Event Type  Other  

Event Description

Sorin group received a report that the s3 double head pump continued to rotate very slowly even when the speed control knob was set to zero.There was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s3 double head 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 s3 double head pump continued to rotate very slowly even when the speed control knob was set to zero.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

As a result of the investigation of the returned base plate with harness and backplane board, the described problem could not be reproduced.Integrated in an s3 test bench, all parts performed functional testing without any issues.Additional test run for approximately 24 hours with different adjustments and different rotational speeds found no deviations.No nonconformities were noted in the manufacturing record review.The parts will be scrapped.The issue will be monitored for trends and identified, corrections will be recommended.

• Brand Name: S3 OUBLE HEAD PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich D 809 39; GM D 80939
• Manufacturer Contact: cheri voorhees, mgr, qa ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3927319
• MDR Text Key: 4669644
• Report Number: 1718850-2014-00206
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/04/2014

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: 10-65-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 07/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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