MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH 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 Consequences Or Impact To Patient (2199)

Event Date 02/05/2015

Event Type  malfunction  

Event Description

Sorin group (b)(4) found that fluid had leaked into the centrifugal pump drive unit causing the unit to be noisy and abnormally warm.There was no patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the centrifugal pump system.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) found that fluid had leaked into the centrifugal pump drive unit causing the unit to be noisy and abnormally warm.There was no patient injury.The investigation is ongoing.A follow up report will be sent when the investigation is complete.

Manufacturer Narrative

(b)(4) manufactures the centrifugal pump system with tubing clamp.The event occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).A (b)(4) field service representative was dispatched to the facility to investigate.The service representative provided a loaner unit to the customer and the replaced unit was returned to (b)(4) for further evaluation.During investigation at (b)(4), the noise issue could be reproduced.Upon further inspection, signs of fluid ingress and dirt were noted in the housing of the device which prevented movement of the roller bearing.The device was cleaned and disinfected and a new rotor and bearing were installed.A technical safety inspection and functional check were successfully completed and the drive unit 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: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; lindbergh strasse 25; munchen 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: 4929618
• MDR Text Key: 15836604
• Report Number: 9611109-2015-00239
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-01-00
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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