MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S3 MAST PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE

Model Number 50-70-10

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

Patient Problem No Patient involvement (2648)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report that the s3 mast pump displayed an error message during preventative maintenance.There was no patient involvement.

Manufacturer Narrative

There was no patient involvement.Sorin group (b)(4) manufactures the s3 mast 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 s3 mast pump displayed an error message during preventative maintenance.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

(b)(4) manufactures the s3 mast pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The device was returned to livanova (b)(4) for evaluation and repair.During the evaluation, it was found that the front panel was defective and caused the reported failure.The front panel was replaced to resolve the issue.The device was cleaned and disinfected.A testrun was performed without further failure and the device was returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• Brand Name: S3 MAST PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindberghstr. 25; munich D 809 39; GM D 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: 4763352
• MDR Text Key: 21544930
• Report Number: 9611109-2015-00124
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K972321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2017

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: 50-70-10
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 05/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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