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

Catalog Number 042001000

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The lot of the circuit and/or the oxygenator are unknown.The expiration date and the unique identifier (udi) therefore also unknown.The oxygenator has been discarded by the user.The lot of the circuit and/or the oxygenator are unknown.The manufacturing date therefore also unknown.The involved oxygenator and circuit have been discarded.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova usa in has received a report stating that after nearly one (1) hour the procedure begins, the arterial line tubing popped off from the oxygenator blood inlet.No high-pressure alarm was triggered.Perfusionist promptly reconnected the line and resumed the procedure.There is no report of any patient injury.During follow up with the customer, it was confirmed: the circuit was primed circuit with no issue; the procedure was initial with no issue; when flow went to zero, the lines had been clamped, reconnected, a tie band was added to the connection that popped off, lines were de-aired, medical team managed to go back on pump and complete the procedure without any additional issue; according to perfusionist estimation, the patient was off pump about 10 seconds during mild hypothermia; the medical center is using this pack/oxy for many years and never seen this.The perfusionist is now using a gun tie on this connection; the medical team revised all documentation of line pressures, flows, resistances, any potential manipulation of tubing at the field and could not find any irregularities.

Event Description

See initial report.

Manufacturer Narrative

The complained circuit was not made available for investigation.No photographic evidence was available.A review of the dhr did not identify any deviations, non-conformities, or material scrap/requests relevant to the reported issue.No other similar complaint was received for the claimed lot.According to technical documentation of the circuit, the tubing from revolution pump to oxygenator inlet is provided to customer as not pre-connected, the claimed connection is assembled by the medical team during the setup of the circuit.Livanova investigation could not identify any device related malfunction: the issue faced by customer is not attributable to a defective product.Product ifus provide warning for using tie band while connecting tubing to oxygenator inlet connector.According to follow up investigation with the customer, presence of a securing tie band could not be confirmed.However, the customer committed to implement a gun tie on this connection for future procedures.Livanova will keep monitoring the market for similar events.Device not available.

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Type of Device: COBE SMARXT TUBING AND CONNECTORS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 10122145
• MDR Text Key: 208351112
• Report Number: 1718850-2020-00025
• 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: 07/20/2020

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 Catalogue Number: 042001000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1