MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND VENOUS LINE CLAMP; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 12-40-00

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2021

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a venous line clamp did not respond when closing or opening during maintenance.Reportedly the clamp is not blocked.There was no patient involvement.

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the venous line clamp.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H.10: the unit was sent to manufacturer for repair and not yet received.Complaints database analysis revealed no similar event for this specific device since its installation in 1998.Based on the current level of information and considering that venous clamp has a mechanical remote control, it cannot be ruled out that degradation of mechanical components or dirt accumulation with contribution of aging may have led to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

The affected device was returned to the manufacturer site for repair.The reported issue could be confirmed.The clamp was disassembled, greased and fixed.Subsequent functional verification testing was completed without further issues and the unit was returned to service.

Event Description

See initial report.

• Brand Name: VENOUS LINE CLAMP
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 12801806
• MDR Text Key: 282737987
• Report Number: 9611109-2021-00639
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: RE
• PMA/PMN Number: K082344
• 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,Followup,Followup
• Report Date: 11/10/2021

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
• Device Model Number: 12-40-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 12/14/2021; 06/03/2022
• Supplement Dates FDA Received: 01/11/2022; 06/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/09/1998
• 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