MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 ERC TUBING CLAMP / 500MM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 60-05-60

Device Problems Failure to Align (2522); Device Displays Incorrect Message (2591); Mechanical Jam (2983); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.Livanova deutschland manufactures the erc device.The incident occurred in (b)(6).The defective component was replaced with a new one.The device has been positively tested and found to be working for specification before to return in service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report about a clamp not working and giving and error code e106.Mechanical jamming of the motor because of misalignment or foreign bodies.No evidence of patient involvement.

Manufacturer Narrative

Deviation could be reproduced during the investigation at the manufacturer site.Root cause was identified as residues of dried fluids and corrosion.Corrective action is in progress for this issue.

Event Description

See initial report.

• Brand Name: S5 ERC TUBING CLAMP / 500MM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 10429988
• MDR Text Key: 204597252
• Report Number: 9611109-2020-00472
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 60-05-60
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2020
• Patient Sequence Number: 1