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

Model Number 60-02-15

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.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 and traced the failure to a defective encoder.The technician replaced the encoder to resolve the reported issue.The defective encoder was returned to livanova deutschland for further investigation.During the evaluation the reported issue could be confirmed but as the device is not manufactured by livanova a specific root cause could not be determined.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

Event Description

Livanova deutschland received a report that a knob of a centrifugal pump system with tubing clamp was hard to be rotated during procedure.There was no report of patient injury.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• 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: njemile crawley ; 14401 w. 65th way; arvada, CO 80004 ; 2812287575
• MDR Report Key: 8508401
• MDR Text Key: 141751036
• Report Number: 9611109-2019-00249
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04003381790098
• UDI-Public: 01040033817900986111808012160S14748
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K032213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2018
• 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