MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND CONTROL PUMP SPEED CARDIOPULMONARY BYPASS; CENTRIFUGAL PUMP

Model Number 96-414-120

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

Patient Problem No Patient involvement (2648)

Event Date 02/25/2015

Event Type  Other  

Event Description

The sorin group field svc rep was at the facility performing a pm.He found the flow sensor tubing needed to be pushed down in order to fully read, which could result in an incorrect flow display.There was no pt involvement.

Manufacturer Narrative

There was no pt involvement.The serial number is unk at this time.Without the serial number, the manufacturing date is unk at this time.Sorin group (b)(4) manufactures the flow sensor.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The sorin group svc rep was at the facility performing a pm.He found the flow sensor tubing needed to be pushed down in order to fully read, which could result in an incorrect flow display.There was no pt involvement.The investigation is ongoing.A f/u report will be sent when the investigation is complete.

Manufacturer Narrative

(b)(4).Device manufacture date: 10/07/2011.(b)(4) manufactures the scp flow sensor.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 was unable to reproduce the reported issue during testing.The flow sensor worked as expected throughout the functional test.As a precaution, the service technician replaced the flow sensor.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• Brand Name: CONTROL PUMP SPEED CARDIOPULMONARY BYPASS
• Type of Device: CENTRIFUGAL PUMP
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindbergh strasse 25; munchen 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: 4687968
• MDR Text Key: 17295939
• Report Number: 9611109-2015-00108
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-414-120
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2011
• 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