MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Serial- and part number are unknown.This information will be provided in a supplemental report if made available.Submitter information are unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova deutschland manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue.The technician replaced the shaft angle encoder and knob to resolve the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a centrifugal pump system with tubing clamp encoder was found to be blocked during setup.There is no known patient involvement.

Manufacturer Narrative

Livanova deutschland received the customer information.The shaft encoder was returned to livanova deutschland for further investigation.During the evaluation the stuck shaft encoder could be confirmed.As the device is not manufactured by livanova deutschland a root cause could not be established.Therefore the encoder was sent to the manufacturer for further evaluation.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8412188
• MDR Text Key: 138815435
• Report Number: 9611109-2019-00151
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K032213
• 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: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 03/15/2019
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1