MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH ELECTRICAL VENOUS OCCLUDER (EVO); CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 28-95-70

Device Problems Device Alarm System (1012); Difficult to Open or Close (2921)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.Livanova (b)(4) manufactures the evo clamp.The incident occurred in (b)(6).Livanova initiated an investigation.Livanova service engineer visit the customer and performed: evo potentiometer check.Clear nvmem evo and occluder.Terminal recalibrated to end point.Function check and test run ok.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.".

Event Description

Livanova received report related to clamp error 1538.No patient involvement reported.

Event Description

See initial report.

Manufacturer Narrative

Medical device problem code has been updated since the code included in the initial report was incorrect.H.10: the error reported by the user is associated to the clamp encoder.A livanova field service technician was dispatched to the customer facility.The reported error code was not reproduced and the unit worked within specification.As per maintenance guidelines, the nvmem of the evo was cleared and a pinpoint calibration was performed.The unit was then put back in service in its expected function.Based on all the above facts, hardware malfunctions can be excluded as cause of the event.It cannot be ruled out that an incorrect tubing size / material may have led to the reported error.

• Brand Name: ELECTRICAL VENOUS OCCLUDER (EVO)
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 12376369
• MDR Text Key: 268445192
• Report Number: 9611109-2021-00474
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: 12E01364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

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: 28-95-70
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1