MAUDE Adverse Event Report: LIVANOVA USA INC SMARXT TUBING AND CONNECTORS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 044051801

Device Problem Misassembled (1398)

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

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

The availability of the involved has not been clarified.A review of the dhr was not possible as no lot was provided.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova usa inc.Has received a report that at the packaging opening, a kink in the outlet tubing of the pump was identified.The kinked outlet tubing was cut and set-up was completed.The cut caused the length of the inlet and outlet tubing to not be any longer the same length.After 138 minutes after the begin of the by-pass was initiated, a flow reduction was noticed.The cause was found to be that the inflow from the cardiotomy and the inlet of the pump had kinked.According to medical team, this generated the following sequence of events, negative pressure was generated, which caused air to come out from solution, which moved to the oxygenator and arterial line, air triggered the bubble detector to stop the pump.The surgeon was informed and arterial line was disconnected, purged and reconnected.Patient consequence were not clarified.

Manufacturer Narrative

Livanova received a report stating that a kink was noticed in the inflow and outflow lines of the centrifugal pump during the set-up.The lined were cut by the user the procedure was started.After 138 minutes after the beginning of the bypass, a reduction of the flow was noted: the line from the cardiotomy to the inlet of the centrifugal pump was kinked.There is no report of any patient injury.Follow up clarification with the customer could not clarify why, having the issue been identified during set-up, the user decided to modify the length of the tubing instead of replacing the circuit.The availability of the involved has not been clarified.The batch of the complained circuit was not provided.Review of the livanova complaint databased found another similar event related to the same circuit item, occurred three days before the present event.Investigation of the previous event suggested the kink was due to an operator error during the manual assembly of the circuit at the livanova facilities.To prevent reoccurrence, the manufacturing personnel has been informed of this issue during formal training meeting.The risk is acceptable.No other corrective action is deemed necessary.Livanova will maintain to monitoring the market.H3 other text : the availability of the involved has not been clarified.

Event Description

See initial report.

• Brand Name: SMARXT TUBING AND CONNECTORS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 11019093
• MDR Text Key: 225175710
• Report Number: 1718850-2020-00046
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K981613
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 044051801
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1