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

Catalog Number 627427601

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

No patient information has been provided.The complained circuit was not made available for investigation.Livanova usa inc manufactures the complained circuit.The incident occurred in (b)(4).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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, during a procedure, the arterial line tubing disconnected from the connector that was used to add additional length of tubing during an extended support case (several days).According to information, (i) the patient had a blood loss and was administered of blood banck, (ii) the circuit has been used for 3 weeks and (iii) the final patient demise was not clarified.

Manufacturer Narrative

Livanova received a report stating that arterial line disconnected at a connector that was used to add additional length of 3/8"tubing during an extended support case.The patient required blood transfusion.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.The involved parts (oxygenator, tubing and pumps) were requested for a detailed investigation but were not made available.Based on the investigations performed for similar cases, the root cause of the reported event was traced back to an alteration of the chemical / mechanical characteristics of the tubings (which are supplied by a livanova supplier).The supplier has been formally informed of the issue.No specific action was currently deemed necessary, livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Type of Device: SMARXT TUBING AND CONNECTORS
• Manufacturer (Section D): LIVANOVA USA INC; arvada CO 80004
• MDR Report Key: 11384515
• MDR Text Key: 233728659
• Report Number: 1718850-2021-00026
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622145612
• UDI-Public: (01)00803622145612(240)627427601(17)220930(10)2027200068
• 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: 04/27/2021

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 Expiration Date: 09/30/2022
• Device Catalogue Number: 627427601
• Device Lot Number: 2027200068
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1