MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP.; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS.

Model Number 60-01-00

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

Patient Problem No Patient involvement (2648)

Event Date 05/11/2015

Event Type  Other  

Event Description

Sorin group (b)(4) received a report that during installation, the centrifugal pump had an intermittent failure.The flow display showed dashes, alarmed and then returned to normal.There was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the centrifugal pump system.The incident occured in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that during installation the centrifugal pump had an intermittent failure.The flow display showed dashes, alarmed and then returned to normal.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

The device serial number provided in the initial report was incorrect.The correct device serial number is (b)(4).The device manufacture date provided in the initial report was incorrect.The correct device manufacture date is july 6, 2007.Livanova (b)(4) manufactures the centrifugal pump system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative identified a faulty drive unit which was removed and returned to livanova (b)(4) for investigation.The reported issue could not be reproduced at livanova (b)(4).The device was cleaned and disinfected and a test run of 24 hours was performed without issue.As the issue was not reproduced, a root cause could not be determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• Brand Name: STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP.
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS.
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; lindbergh strasse 25; munich D8093 9; GM D80939
• 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: 4863447
• MDR Text Key: 5846808
• Report Number: 9611109-2015-00223
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032213
• 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

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-01-00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2007
• 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