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

Catalog Number	044053500
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were not provided.Livanova usa manufactures the smarxt tubing and connectors.The incident occurred in (b)(6) united states of america.The involved device has been requested for return to livanova usa for investigation and received on july 29, 2021.Visual inspection confirmed the reported white stretch substance present between the outside of the connector and the inside of the tubing.Substance appears to be a very small piece of a white rubber glove, which is the type of glove used in the livanova usa manufacturing cleanroom.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa has received a report that, after setting up, priming and going on pump, the perfusionist noticed the presence of white material lodged in-between the connector and the tubing.They cut it out and replaced it with another line.There is no report of any patient injury.
Additional Manufacturer Narrative
Livanova received a report stating that a white stretchy substance was found to be lodged between the outside of the connector and the inside of the tubing.The issue occurred during the unpacking.No patient / user affected.Portion of prime/recirc line from pack pn 044053500 lot 2110900016 was requested for a dedicated analysis.The line was visually inspected: visual inspection under normal vision revealed the presence of a white rubber glove similar used by manufacturing personal.Thus, the reported condition was confirmed.The complaints database did not reveal further reported issues related to units belonging to this lot.Based on all the above facts, the root cause of the reported event was traced back to an operator error in the manufacturing line.The personnel will be involved in a dedicated training meeting aimed to make personal aware of customer complaint.Livanova will maintain monitoring the market.
Event or Problem Description
See intial report.

• Brand Name: COBE SMARXT TUBING AND CONNECTORS
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 12279134
• Report Number: 1718850-2021-00043
• Device Sequence Number: 3971096
• Product Code: DWE
• UDI-Device Identifier: 00803622140099
• UDI-Public: (01)00803622140099(240)230430(17)044053500(10)2110900016
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 044053500
• Device Lot Number: 2110900016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1