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

Model Number 60-00-60

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight was not provided.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the centrifugal pump 5.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was not able to confirm the reported issue.The technician replaced the whole pump and sent it to livanova (b)(4) for further investigation and repair.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.

Event Description

On 13th february 2018 livanova (b)(4) received a medwatch report which indicated that a centrifugal pump 5 stopped delivering the flow during the procedure.The customer switched to a different pump and was able to finish the surgery without patient harm.There was no report of patient injury.

Manufacturer Narrative

The complaint pump was returned to livanova (b)(4) for further investigation.During the investigation the reported device was tested intensively but no failure could be confirmed or reproduced.The device worked according to specifications.

• Brand Name: CENTRIFUGAL PUMP 5
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7326331
• MDR Text Key: 102123068
• Report Number: 9611109-2018-00196
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-00-60
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR