MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-00-60

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).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 replaced the touchscreen and reset the circuit to resolve the issue.Subsequent functional verification testing was completed without issue.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova received a report that the touchscreen of the centrifugal pump 5 (cp5) became unresponsive when the perfusionist pressed the minimum speed button during a procedure.The control panel of the cp5 was restarted and after several attempts the minimum speed button responded.After the procedure, the perfusionist tested to cp5 and was able to reproduce the issue.There was no report of patient injury.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 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: 6874225
• MDR Text Key: 87332967
• Report Number: 9611109-2017-00728
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-00-60
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• 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
• Patient Age: 70 YR
• Patient Weight: 78